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Aeon

EUDAMEDFDA 510(k)FDA UDI

Class IIa (EU MDR)

Ref AEPH160Ref ASR30PSRef AEPH060Ref ASR60WSRef AETH060Ref AESR60WRef AESH260Ref AESR45WRef ASR30WSRef AESC45WRef AESC60WRef AESR45BRef AESC45PModel AESR45PRef AESH160Ref ASR30RCRef AESR60BRef ASR30WCRef AESR45RRef AESPHCURef AESC60P510(k) K180114510(k) K192235Ref AEPH260Ref AESR60PRef ASR30PCRef AESR45GRef ASR30GSRef AESC45RRef AETH160Ref AESR60RRef ASR45RS

by Lexington Medical Inc.

Identity

Trade Name
AEON EUDAMEDFDA UDI
Generic Name
Endoscopic manual linear cutting stapler, single-use FDA UDI
Motorized cutting stapler handpiece FDA UDI
Device Name
AEON Endoscopic Powered Stapler Handle - Medium EUDAMED
AEON Endoscopic Stapler 30mm Short Tip Reload, 4.0mm/1.8mm EUDAMED
AEON Endoscopic Powered Stapler Handle - Short EUDAMED
AEON Endoscopic Stapler 60mm Short Tip Reload, 2.5mm/1.0mm EUDAMED
AEON Endoscopic Stapler Plus Handle Short EUDAMED
AEON Endoscopic Powered Stapler EUDAMED
AEON Endoscopic Stapler 60mm Reload, 2.5mm/1.0mm EUDAMED
AEON Endoscopic Stapler Handle Long EUDAMED
AEON Endoscopic Stapler 45mm Reload, 2.5mm/1.0mm EUDAMED
AEON Endoscopic Stapler 30mm Short Tip Reload, 2.5mm/1.0mm EUDAMED
AEON Endoscopic Stapler 45mm Curved Tip Reload, 2.5mm/1.0mm EUDAMED
AEON Endoscopic Stapler 60mm Curved Tip Reload, 2.5mm/1.0mm EUDAMED
AEON Endoscopic Stapler 45mm Reload, 5.0mm/2.2mm EUDAMED
AEON Endoscopic Stapler 45mm Reload, 4.0mm/1.8mm EUDAMED
AEON Endoscopic Stapler Handle Medium EUDAMED
AEON Endoscopic Stapler 30mm Curved Tip Reload, 3.25mm/1.5mm EUDAMED
AEON Endoscopic Stapler 60mm Reload, 5.0mm/2.2mm EUDAMED
AEON Endoscopic Stapler 30mm Curved Tip Reload, 2.5mm/1.0mm EUDAMED
AEON Endoscopic Stapler 45mm Reload, 3.25mm/1.5mm EUDAMED
AEON Control Unit EUDAMED
AEON Endoscopic Stapler 60mm Curved Tip Reload, 4.0mm/1.8mm EUDAMED
AEON Endoscopic Powered Stapler Handle - Long EUDAMED
AEON Endoscopic Stapler 60mm Reload, 4.0mm/1.8mm EUDAMED
AEON Endoscopic Stapler 30mm Curved Tip Reload, 4.0mm/1.8mm EUDAMED
AEON Endoscopic Stapler 45mm Reload, 2.0mm/0.75mm EUDAMED
AEON Endoscopic Stapler 30mm Short Tip Reload, 2.0mm/0.75mm EUDAMED
AEON Endoscopic Stapler 45mm Curved Tip Reload, 3.25mm/1.5mm EUDAMED
AEON Endoscopic Stapler Plus Handle Medium EUDAMED
AEON Endoscopic Stapler 60mm Reload, 3.25mm/1.5mm EUDAMED
AEON Endoscopic Stapler 45mm Short Tip Reload, 3.25mm/1.5mm EUDAMED
Endoscopic Stapler Handle - Medium FDA UDI
Endoscopic Stapler 30mm Short Tip Reload 2.5mm/1.0mm FDA UDI
Endoscopic Stapler 30mm Curved Tip Reload 2.5mm/1.0mm FDA UDI
Endoscopic Stapler Handle Plus Short FDA UDI
Endoscopic Powered Stapler - Short - 6PK FDA UDI
Endoscopic Stapler 45mm Curved Tip Reload 3.25mm/1.5mm FDA UDI
Endoscopic Stapler Handle - Long FDA UDI
Endoscopic Stapler 30mm Curved Tip Reload 3.25mm/1.5mm FDA UDI
Endoscopic Powered Stapler - Medium - 6PK FDA UDI
Endoscopic Stapler 60mm Reload 5.0mm/2.2mm FDA UDI
Endoscopic Stapler 45mm Curved Tip Reload 2.5mm/1.0mm FDA UDI
Endoscopic Stapler 60mm Short Tip Reload 2.5mm/1.0mm FDA UDI
Endoscopic Stapler 45mm Reload 3.25mm/1.5mm FDA UDI
Endoscopic Stapler 60mm Curved Tip Reload 4.0mm/1.8mm FDA UDI
Endoscopic Powered Stapler - Long - 6PK FDA UDI
Endoscopic Powered Stapler - Short FDA UDI
Model / Reference
AEPH160 EUDAMEDFDA UDI
ASR30PS EUDAMED
AEPH060 EUDAMEDFDA UDI
ASR60WS EUDAMEDFDA UDI
AETH060 EUDAMEDFDA UDI
AESR60W EUDAMED
AESH260 EUDAMEDFDA UDI
AESR45W EUDAMED
ASR30WS EUDAMEDFDA UDI
AESC45W EUDAMEDFDA UDI
AESC60W EUDAMED
AESR45B EUDAMED
AESR45P EUDAMED
AESC45P EUDAMED
AESH160 EUDAMEDFDA UDI
ASR30RC EUDAMEDFDA UDI
AESR60B EUDAMEDFDA UDI
ASR30WC EUDAMEDFDA UDI
AESR45R EUDAMEDFDA UDI
AESPHCU EUDAMED
AESC60P EUDAMEDFDA UDI
AESC45R EUDAMEDFDA UDI
AEPH260 EUDAMEDFDA UDI
AESR60P EUDAMED
ASR30PC EUDAMED
AESR45G EUDAMED
ASR30GS EUDAMED
AETH160 EUDAMED
AESR60R EUDAMED
ASR45RS EUDAMED
Description
Endoscopic Stapler Handle - Medium FDA UDI
Endoscopic Stapler 30mm Short Tip Reload 2.5mm/1.0mm FDA UDI
Endoscopic Stapler 30mm Curved Tip Reload 2.5mm/1.0mm FDA UDI
Endoscopic Stapler Handle Plus Short FDA UDI
Endoscopic Powered Stapler - Short - 6PK FDA UDI
Endoscopic Stapler 45mm Curved Tip Reload 3.25mm/1.5mm FDA UDI
Endoscopic Stapler Handle - Long FDA UDI
Endoscopic Stapler 30mm Curved Tip Reload 3.25mm/1.5mm FDA UDI
Endoscopic Powered Stapler - Medium - 6PK FDA UDI
Endoscopic Stapler 60mm Reload 5.0mm/2.2mm FDA UDI
Endoscopic Stapler 45mm Curved Tip Reload 2.5mm/1.0mm FDA UDI
Endoscopic Stapler 60mm Short Tip Reload 2.5mm/1.0mm FDA UDI
Endoscopic Stapler 45mm Reload 3.25mm/1.5mm FDA UDI
Endoscopic Stapler 60mm Curved Tip Reload 4.0mm/1.8mm FDA UDI
Endoscopic Powered Stapler - Long - 6PK FDA UDI
Endoscopic Powered Stapler - Short FDA UDI

Identifiers

Catalog Number
ASR30RC FDA UDI
Primary DI / UDI-DI
00850060791079 EUDAMEDFDA UDI
00851574008516 EUDAMED
00850060791062 EUDAMEDFDA UDI
00851574008233 EUDAMED
00851574008653 EUDAMED
00851574008462 EUDAMED
00851574008912 EUDAMED
00851574008035 EUDAMED
00851574008899 EUDAMED
00851574008332 EUDAMED
00851574008103 EUDAMED
00851574008257 EUDAMED
00851574008646 EUDAMED
00851574008875 EUDAMED
00851574008011 EUDAMED
00851574008592 EUDAMED
00851574008714 EUDAMED
00851574008318 EUDAMED
00851574008806 EUDAMEDFDA UDI
00850060791093 EUDAMED
00851574008172 EUDAMED
00851574008004 EUDAMEDFDA UDI
00851574008325 EUDAMEDFDA UDI
00851574008301 EUDAMEDFDA UDI
00851574008769 EUDAMEDFDA UDI
00851574008967 EUDAMEDFDA UDI
00851574008028 EUDAMEDFDA UDI
00851574008707 EUDAMEDFDA UDI
00851574008110 EUDAMEDFDA UDI
00851574008226 EUDAMEDFDA UDI
00851574008165 EUDAMEDFDA UDI
00850060791086 EUDAMEDFDA UDI
00850060791048 EUDAMEDFDA UDI
00851574008639 EUDAMED
00851574008738 EUDAMED
00851574008530 EUDAMED
00851574008622 EUDAMED
00851574008851 EUDAMED
00851574008394 EUDAMED
00851574008486 EUDAMED
00851574008677 EUDAMED
00850060791109 EUDAMED
00851574008349 EUDAMED
00851574008585 FDA UDI
Basic UDI-DI
B-00850060791079 EUDAMED
B-00851574008516 EUDAMED
B-00850060791062 EUDAMED
B-00851574008233 EUDAMED
B-00851574008653 EUDAMED
0851574008ENDOSHANDLEZS EUDAMED
B-00851574008912 EUDAMED
B-00851574008035 EUDAMED
B-00851574008899 EUDAMED
B-00851574008332 EUDAMED
B-00851574008103 EUDAMED
B-00851574008257 EUDAMED
B-00851574008646 EUDAMED
B-00851574008875 EUDAMED
B-00851574008011 EUDAMED
B-00851574008592 EUDAMED
B-00851574008714 EUDAMED
B-00851574008318 EUDAMED
B-00851574008806 EUDAMED
B-00850060791093 EUDAMED
B-00851574008172 EUDAMED
B-00851574008639 EUDAMED
B-00851574008738 EUDAMED
B-00850060791086 EUDAMED
B-00851574008530 EUDAMED
B-00851574008707 EUDAMED
B-00851574008851 EUDAMED
B-00851574008165 EUDAMED
B-00851574008004 EUDAMED
B-00851574008226 EUDAMED
B-00851574008028 EUDAMED
B-00851574008394 EUDAMED
B-00851574008769 EUDAMED
B-00851574008325 EUDAMED
B-00851574008967 EUDAMED
B-00851574008301 EUDAMED
B-00851574008110 EUDAMED
B-00851574008486 EUDAMED
B-00851574008677 EUDAMED
B-00850060791109 EUDAMED
B-00850060791048 EUDAMED
510(k) Number
K180114 FDA 510(k)
K192235 FDA 510(k)
K171589 FDA UDI
K234039 FDA UDI
FDA Product Code
GCJ FDA 510(k)
GEI FDA 510(k)
GDW FDA UDI
GAG FDA UDI
EMDN Code
H020301050102 SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY EUDAMED
H020301050299 SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY – OTHER EUDAMED
GMDN Term
Endoscopic manual linear cutting stapler, single-use FDA UDI
Motorized cutting stapler handpiece FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
878.4400 FDA 510(k)
878.4750 FDA UDI
878.4740 FDA UDI
Market of Registration
Austria EUDAMED
Belgium EUDAMED
Czechia EUDAMED
France EUDAMED
Advisory Committee
Gastroenterology, Urology FDA 510(k)
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMED

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDIEUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDIFDA UDI
MRI Safety
MR Conditional FDA UDI

Aeon by Lexington Medical, Inc. — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Lexington Medical Inc.
EUDAMED SRN
US-MF-000007741
Authorised Representative
Advena Limited MT-AR-000000234

Sources (69)

  • EUDAMED 29fa25cc-537b-4f0b-8242-1b7a9601fe77 61 fields · synced Sep 18, 2026
  • EUDAMED 37328076-88cb-4d43-b215-56c3ec357c14 61 fields · synced May 11, 2026
  • EUDAMED b285b390-d08c-45b7-b55f-4d3a7b276cc2 61 fields · synced May 11, 2026
  • EUDAMED 4953dbce-52e1-476d-b72b-bef62419c66c 61 fields · synced May 16, 2026
  • EUDAMED 2a0e9245-fb06-470d-904a-cde0bd1d7ad5 61 fields · synced May 16, 2026
  • EUDAMED d3cd3fe2-9de4-4e98-873f-41ecec79a004 61 fields · synced May 16, 2026
  • EUDAMED eab23239-0c18-461c-a758-866942d9273e 61 fields · synced May 16, 2026
  • EUDAMED 87a90af6-9c03-4436-8d11-d0bfe5cc08d5 61 fields · synced May 16, 2026
  • EUDAMED d0ab3744-3631-4f57-8a55-c460b457ad6e 61 fields · synced May 17, 2026
  • EUDAMED a87b11ea-501d-4b10-8c1e-bb13a0e1210a 61 fields · synced May 17, 2026
  • EUDAMED 10fa47c5-a0a6-4fd0-bf40-ee9f32fadcc2 61 fields · synced May 17, 2026
  • EUDAMED 4ca1f1b5-40ea-4373-b824-03cb5b51ab78 61 fields · synced May 17, 2026
  • EUDAMED 0234f310-3622-4f17-b683-801c514ded67 61 fields · synced May 17, 2026
  • EUDAMED 08dbe6a6-0d05-4377-8c99-fa2de630ea68 61 fields · synced May 17, 2026
  • EUDAMED fd856716-fc38-426d-8735-3bba97b65631 61 fields · synced May 18, 2026
  • EUDAMED 318b8be6-ea82-40e1-84d1-e8f0d37d9e2c 61 fields · synced May 18, 2026
  • EUDAMED a8aef864-66d0-41ea-a7f3-59d1d7540bba 61 fields · synced May 18, 2026
  • EUDAMED 8f1aa5a3-9206-4692-be79-28c9535e8e0b 61 fields · synced May 18, 2026
  • EUDAMED c748d094-e87d-4436-b841-38c80f074670 61 fields · synced May 18, 2026
  • EUDAMED b099fe65-f098-4e6d-8ab7-7a36d342addb 61 fields · synced May 18, 2026
  • EUDAMED 0f18c0b4-d575-4f31-9023-abe0dc64c941 61 fields · synced May 18, 2026
  • FDA 510(k) K180114 24 fields · synced May 18, 2026
  • FDA 510(k) K192235 24 fields · synced May 18, 2026
  • FDA UDI 0e1e122b-a12a-4827-a855-cb9cb1f3b5e2 34 fields · synced May 29, 2026
  • FDA UDI e6480773-86d2-4c3a-8d10-7c13ab2d8e81 33 fields · synced May 29, 2026
  • FDA UDI 1a558196-d91d-45a7-9c88-08b3d98694b9 33 fields · synced May 29, 2026
  • FDA UDI 23745481-ad74-4033-8349-d0ae794fbf8a 33 fields · synced May 30, 2026
  • FDA UDI 76d42504-b2b0-4449-ba15-7c1d993e54bb 34 fields · synced May 30, 2026
  • FDA UDI e2c8859f-da05-46ff-9c60-ff20c39fb90c 33 fields · synced May 30, 2026
  • FDA UDI 49a3c6cf-2f7c-46cc-949f-e1b838ba2fe3 34 fields · synced May 30, 2026
  • FDA UDI 1a8ea4e3-57d2-40af-bdef-7bb48b87196a 34 fields · synced May 30, 2026
  • FDA UDI f9d99f87-bdfd-452e-87f2-03d87521b857 34 fields · synced May 30, 2026
  • FDA UDI 56f87411-8725-4451-a4e2-1b2506fe62a0 33 fields · synced May 30, 2026
  • FDA UDI 7f264cbb-c95e-44ad-b7a4-79afc84fbbdc 33 fields · synced May 30, 2026
  • FDA UDI 521006eb-0874-4bf8-909b-106e8698e794 33 fields · synced May 30, 2026
  • FDA UDI f980fbd8-3979-4611-b85c-636483fd635e 33 fields · synced May 30, 2026
  • FDA UDI a3534543-6910-499b-9ad6-b7bcfe05c1de 33 fields · synced May 30, 2026
  • FDA UDI 30ee2a25-c324-4af8-ba16-96ef14405051 34 fields · synced May 30, 2026
  • FDA UDI 04993b8d-92ce-44d2-a7d1-343bc2559227 34 fields · synced May 30, 2026
  • EUDAMED 5e8981ae-bcbd-48f1-8ba3-2c0a9df915ae 61 fields · synced Jul 8, 2026
  • EUDAMED 45d43bc5-b0a5-4b7d-b2a3-805d2c7f3bfa 61 fields · synced Jul 9, 2026
  • EUDAMED 930f6f97-b8dd-4c17-914c-3c2166c5dada 61 fields · synced Jul 9, 2026
  • EUDAMED 85ad975d-30b4-46a6-8097-8d365154e239 61 fields · synced Jul 11, 2026
  • EUDAMED 0fc722b0-77a0-4c9f-ad46-28e490c571f1 61 fields · synced Jul 12, 2026
  • EUDAMED 46b89c21-a882-4cb0-97d5-07268fa4c246 61 fields · synced Jul 14, 2026
  • EUDAMED a7110c03-37e4-4625-a4d9-cc32c52aedd9 61 fields · synced Jul 15, 2026
  • EUDAMED b2baa906-6c27-4ab2-ad86-7f885ca4d76e 61 fields · synced Jul 15, 2026
  • EUDAMED 743a8021-da74-4fba-b74c-2621eedc12ad 61 fields · synced Jul 18, 2026
  • EUDAMED 1e207ffa-91a2-4b26-9a12-f327c65d1a45 61 fields · synced Jul 20, 2026
  • EUDAMED 68396369-d718-49ba-b255-1b62cfbc643f 61 fields · synced Jul 20, 2026
  • EUDAMED 3f1975d2-a16e-46ff-8b28-74cd1261bb94 61 fields · synced Jul 20, 2026
  • EUDAMED a7b34187-ea4c-4be0-b033-f43bcce69e5b 61 fields · synced Jul 21, 2026
  • EUDAMED d6245278-30dc-4fcf-aacf-d8832b73c7fb 61 fields · synced Jul 24, 2026
  • EUDAMED 246fa990-9be5-480f-8640-d4afcf7b912c 61 fields · synced Jul 25, 2026
  • EUDAMED b6bdf863-3690-4ca2-a6ad-6c609cd89a65 61 fields · synced Jul 25, 2026
  • EUDAMED ceb4c263-f3d5-4efe-81fc-0114a73aee5c 61 fields · synced Jul 26, 2026
  • EUDAMED 2a3ce6a0-37f9-48f9-9212-05505b466eb9 61 fields · synced Jul 26, 2026
  • EUDAMED 33e8af35-fea1-4067-abb7-800dde669bdf 61 fields · synced Jul 27, 2026
  • EUDAMED 175c2ca9-d673-4884-81e2-f0f2a682f537 61 fields · synced Jul 29, 2026
  • EUDAMED a0cf7890-4872-42d0-bf42-08e2a88f6000 61 fields · synced Aug 1, 2026
  • EUDAMED 28979fa1-c77a-4098-b8cf-88d725cab840 61 fields · synced Aug 2, 2026
  • EUDAMED dc8d026b-5bba-4197-8276-80d204b1e0c7 61 fields · synced Aug 2, 2026
  • EUDAMED 28c36c77-33a9-4353-a3ba-85556c900727 61 fields · synced Aug 2, 2026
  • EUDAMED a0d4ccb1-fd15-4144-a1dd-9512680e1ff7 61 fields · synced Aug 3, 2026
  • EUDAMED 4469a0bd-c029-4098-a9d6-459fd2d974b1 61 fields · synced Aug 4, 2026
  • EUDAMED 5d93d827-61c2-4342-b30b-cdced272638a 61 fields · synced Sep 17, 2026
  • EUDAMED e1f98100-138f-4892-a57f-0d7aca5a657e 61 fields · synced Sep 17, 2026
  • EUDAMED bf43af1c-5dc5-4fe5-bc1e-0c4dd0f9de4d 61 fields · synced Sep 17, 2026
  • EUDAMED ee34ae39-4c70-47c8-8504-35a4365d03dd 61 fields · synced Sep 18, 2026