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Panther Group Of Surgical Includes: Oanther Circular Stapler +2 more models

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K103470Ref FLSL90Ref FCSLWAF32Ref FCSS33Ref FCSLWAE29Ref FLSLG90Ref FCSLWAF25Ref FLSLG60Ref FCSS36Ref FCSME34Ref FCSLWBF33Ref FCSM26Ref FCSMF25Ref FCSSWAF34Ref FCSLWBF34Ref FCSSWAF26Ref FCSSWAE33Ref FCSMF28Ref FCSSWBF21Ref FCSSWBE36Ref FCSLWAE26Ref FLSLF60Ref FLSL30Ref FCSSWBF29Ref FCSSWBF24Ref FCSM29Ref FCSMF29Ref FCSSWBE31Ref FCSMF24Ref FCSSMF26Ref FCSLWBF21Ref FCSM25Ref FCSSME32Ref FCSMF26Ref FCSSWBE32Ref FCSS32Ref FCSSME34Ref FLSLE90Ref FCSME21Ref FCSM24Ref FCSLWAE32Ref FCSME26Ref FCSSWAF21Ref FLSL60Ref FCSLW26Ref FCSMED25Ref FLSLE45Ref FCSME24Ref FCSSWAE31

by B. J. ZH. F. Panther Medical Equipment Co., Ltd.

Identity

Trade Name
PANTHER Linear Stapler EUDAMED
PANTHER Circular stapler EUDAMED
Circular Stapler FDA UDI
Generic Name
Intraluminal circular stapler, single-use FDA UDI
Device Name
Linear Stapler EUDAMED
Circular stapler EUDAMED
Model / Reference
FCSSME34 EUDAMEDFDA UDI
FCSSWAE31 EUDAMEDFDA UDI
FCSME34 EUDAMEDFDA UDI
FCSSWBE32 EUDAMEDFDA UDI
FCSME26 EUDAMEDFDA UDI
FCSME24 EUDAMEDFDA UDI
FCSSWBE31 EUDAMEDFDA UDI
FCSSME32 EUDAMEDFDA UDI
FCSSWAE33 EUDAMEDFDA UDI
FLSL90 EUDAMED
FCSLWAF32 EUDAMED
FCSS33 EUDAMED
FCSLWAE29 EUDAMED
FLSLG90 EUDAMED
FCSLWAF25 EUDAMED
FLSLG60 EUDAMED
FCSS36 EUDAMED
FCSLWBF33 EUDAMED
FCSM26 EUDAMED
FCSMF25 EUDAMED
FCSSWAF34 EUDAMED
FCSLWBF34 EUDAMED
FCSSWAF26 EUDAMED
FCSMF28 EUDAMED
FCSSWBF21 EUDAMED
FCSSWBE36 EUDAMED
FCSLWAE26 EUDAMED
FLSLF60 EUDAMED
FLSL30 EUDAMED
FCSSWBF29 EUDAMED
FCSSWBF24 EUDAMED
FCSM29 EUDAMED
FCSMF29 EUDAMED
FCSMF24 EUDAMED
FCSSMF26 EUDAMED
FCSLWBF21 EUDAMED
FCSM25 EUDAMED
FCSMF26 EUDAMED
FCSS32 EUDAMED
FLSLE90 EUDAMED
FCSME21 EUDAMED
FCSM24 EUDAMED
FCSLWAE32 EUDAMED
FCSSWAF21 EUDAMED
FLSL60 EUDAMED
FCSLW26 EUDAMED
FCSMED25 EUDAMED
FLSLE45 EUDAMED

Identifiers

Primary DI / UDI-DI
06939282438611 EUDAMEDFDA UDI
06939282438505 EUDAMEDFDA UDI
06939282448740 EUDAMEDFDA UDI
06939282438550 EUDAMEDFDA UDI
06939282448719 EUDAMEDFDA UDI
06939282448702 EUDAMEDFDA UDI
06939282438543 EUDAMEDFDA UDI
06939282438598 EUDAMEDFDA UDI
06939282438529 EUDAMEDFDA UDI
06939282499117 EUDAMED
06939282401479 EUDAMED
06939282438383 EUDAMED
06939282418521 EUDAMED
06939282499230 EUDAMED
06939282401455 EUDAMED
06939282499223 EUDAMED
06939282438192 EUDAMED
06939282401547 EUDAMED
06939282448283 EUDAMED
06939282448672 EUDAMED
06939282438796 EUDAMED
06939282401554 EUDAMED
06939282438734 EUDAMED
06939282448665 EUDAMED
06939282438802 EUDAMED
06939282438765 EUDAMED
06939282418514 EUDAMED
06939282499186 EUDAMED
06939282499087 EUDAMED
06939282438840 EUDAMED
06939282438819 EUDAMED
06939282448481 EUDAMED
06939282448771 EUDAMED
06939282448757 EUDAMED
06939282403732 EUDAMED
06939282401509 EUDAMED
06939282448184 EUDAMED
06939282448764 EUDAMED
06939282438086 EUDAMED
06939282499155 EUDAMED
06939282446753 EUDAMED
06939282448085 EUDAMED
06939282418538 EUDAMED
06939282438772 EUDAMED
06939282499100 EUDAMED
06939282418187 EUDAMED
06939282448832 EUDAMED
06939282499131 EUDAMED
Basic UDI-DI
B-06939282499117 EUDAMED
B-06939282401479 EUDAMED
B-06939282438383 EUDAMED
B-06939282418521 EUDAMED
B-06939282499230 EUDAMED
B-06939282401455 EUDAMED
B-06939282499223 EUDAMED
B-06939282438192 EUDAMED
B-06939282448740 EUDAMED
B-06939282401547 EUDAMED
B-06939282448283 EUDAMED
B-06939282448672 EUDAMED
B-06939282438796 EUDAMED
B-06939282401554 EUDAMED
B-06939282438734 EUDAMED
B-06939282438529 EUDAMED
B-06939282448665 EUDAMED
B-06939282438802 EUDAMED
B-06939282438765 EUDAMED
B-06939282418514 EUDAMED
B-06939282499186 EUDAMED
B-06939282499087 EUDAMED
B-06939282438840 EUDAMED
B-06939282438819 EUDAMED
B-06939282448481 EUDAMED
B-06939282448771 EUDAMED
B-06939282438543 EUDAMED
B-06939282448757 EUDAMED
B-06939282403732 EUDAMED
B-06939282401509 EUDAMED
B-06939282448184 EUDAMED
B-06939282438598 EUDAMED
B-06939282448764 EUDAMED
B-06939282438550 EUDAMED
B-06939282438086 EUDAMED
B-06939282438611 EUDAMED
B-06939282499155 EUDAMED
B-06939282446753 EUDAMED
B-06939282448085 EUDAMED
B-06939282418538 EUDAMED
B-06939282448719 EUDAMED
B-06939282438772 EUDAMED
B-06939282499100 EUDAMED
B-06939282418187 EUDAMED
B-06939282448832 EUDAMED
B-06939282499131 EUDAMED
B-06939282448702 EUDAMED
B-06939282438505 EUDAMED
510(k) Number
K103470 FDA 510(k)
FDA Product Code
GDW FDA 510(k)FDA UDI
EMDN Code
H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
H0202020201 SINGLE-USE CURVED CIRCULAR STAPLERS FOR OPEN SURGERY EUDAMED
GMDN Term
Intraluminal circular stapler, single-use FDA UDI
Models / Variants
Panther Hemorrhoidal Circular Stapler FDA 510(k)FDA UDIEUDAMED
Panther Linear Stap FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.4750 FDA 510(k)
Regulation Number
878.4750 FDA 510(k)FDA UDI
Market of Registration
Spain EUDAMED
Advisory Committee
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 UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

No

FDA 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Safe FDA UDI

The Panther Circular Stapler, Panther Hemorrhoidal Circular Stapler, and Panther Linear Stapler are surgical stapling devices designed for tissue approximation and resection. These instruments use titanium staples to create secure anastomoses or excise tissue in a controlled manner. The circular staplers are specifically engineered to form circular connections in tubular structures, while the linear staplers provide precise cutting and stapling along straight tissue planes. All models are manual, single-use devices intended for open or laparoscopic procedures.

These devices are supplied sterile and intended for single-patient use. The Panther Circular Stapler applies double or triple staggered rows of titanium staples while simultaneously resecting tissue, forming a circular anastomosis. The Panther Hemorrhoidal Circular Stapler is tailored for hemorrhoidal procedures, and the Panther Linear Stapler offers cutting and stapling functionality. They are classified as Class II devices under FDA regulations and comply with the Medical Device Directive (MDD). These instruments are not MRI-compatible and must be stored as per manufacturer guidelines to maintain sterility.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Panther Group of Surgical Includes: Oanther Circular Stapler; Panther ..., PDF Product Catalog - Panther Healthcare USA, PDF A J.4 1 01 - Food and Drug Administration

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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

Manufacturer

FDA Applicant
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

Sources (58)

  • FDA 510(k) K103470 24 fields · synced Sep 30, 2026
  • FDA UDI b4c769c7-c30c-4a98-952d-29947158e347 32 fields · synced May 29, 2026
  • FDA UDI 2788f97e-4966-4a99-a66c-3851e48a9aa8 32 fields · synced May 29, 2026
  • FDA UDI 892213c9-9022-4db0-a942-0277c6364a69 32 fields · synced May 30, 2026
  • FDA UDI 3aabbf74-f53c-4e67-b0cb-408c0da200a2 32 fields · synced May 30, 2026
  • FDA UDI 734aa1eb-d8c7-473e-a8b8-d0268e2ea485 32 fields · synced May 30, 2026
  • FDA UDI c13330de-4f34-4614-8f96-46460894c91e 32 fields · synced May 30, 2026
  • FDA UDI e1df1975-1575-4c52-ad6e-99691000fc22 32 fields · synced May 30, 2026
  • FDA UDI 02cbb913-7b76-46c1-b378-4031d2b684d4 32 fields · synced May 30, 2026
  • FDA UDI 00655d60-db74-4e11-bf16-6c4747c10952 32 fields · synced May 30, 2026
  • EUDAMED c0467e69-9299-4692-a780-4365a24edea0 61 fields · synced Jul 8, 2026
  • EUDAMED 696ccd39-36e8-4b2c-8c47-b45e32ecab03 61 fields · synced Jul 9, 2026
  • EUDAMED dc7529d1-aff8-4a59-9732-579ef418fc24 61 fields · synced Jul 9, 2026
  • EUDAMED 73ce7d6e-812c-4b33-a8d8-f3d149e296ba 61 fields · synced Jul 9, 2026
  • EUDAMED de927cfa-eaef-48c8-a237-dcbd0f5baa5b 61 fields · synced Jul 10, 2026
  • EUDAMED 92a836a6-50c2-4519-92d2-68c346db317c 61 fields · synced Jul 10, 2026
  • EUDAMED 8965b784-45a8-423e-8ca6-1d86c4f07dbd 61 fields · synced Jul 10, 2026
  • EUDAMED 476df12e-d837-401f-9b39-82d15e56696a 61 fields · synced Jul 10, 2026
  • EUDAMED bbf23fa7-e158-48d2-bf5d-88356eecb38a 61 fields · synced Jul 11, 2026
  • EUDAMED 96a1a74c-a55b-4c5e-82c7-2922589dbdcb 61 fields · synced Jul 11, 2026
  • EUDAMED 2b640402-d006-4783-94f0-757a92dee02b 61 fields · synced Jul 11, 2026
  • EUDAMED b2167e9e-1c17-4447-9d6d-8cabc7cff1f6 61 fields · synced Jul 12, 2026
  • EUDAMED 2b02138b-997d-46cc-8c48-11e625b7d31f 61 fields · synced Jul 12, 2026
  • EUDAMED 73b9234f-7b9d-4c70-8684-eb52f71be588 61 fields · synced Jul 12, 2026
  • EUDAMED 32ff3980-f991-4d46-848d-57b81573de76 61 fields · synced Jul 12, 2026
  • EUDAMED b4dacc51-083d-46b9-9ecd-82f9e2a6c0d0 61 fields · synced Jul 13, 2026
  • EUDAMED 20baeaac-c514-4909-b10b-b09b931629db 61 fields · synced Jul 13, 2026
  • EUDAMED 6ead9863-9f55-49a7-a6b9-24aa7605fb80 61 fields · synced Jul 13, 2026
  • EUDAMED cdfc5a62-e004-4ad2-b177-e3dcf8e01a2a 61 fields · synced Jul 14, 2026
  • EUDAMED c40eb031-3c84-4e93-bc45-c5ecfa2650f9 61 fields · synced Jul 14, 2026
  • EUDAMED d7fbfcfe-b3ab-468c-b182-f44bd7b3c003 61 fields · synced Jul 14, 2026
  • EUDAMED 534c403c-3b04-4ff0-9b48-94390578da91 61 fields · synced Jul 14, 2026
  • EUDAMED 1aa55b14-8430-4399-961a-525990b4999e 61 fields · synced Jul 16, 2026
  • EUDAMED 5d6ecff0-8292-4f0e-8498-1e675be2188e 61 fields · synced Jul 16, 2026
  • EUDAMED be3a218b-cac8-4190-9e55-68aab310ad1d 61 fields · synced Jul 17, 2026
  • EUDAMED c7546d3d-72f0-486e-981e-e33607561f59 61 fields · synced Jul 17, 2026
  • EUDAMED e8c0fd22-9c09-4b19-859a-7f52728c6a24 61 fields · synced Jul 17, 2026
  • EUDAMED e4f99cf2-5df3-46b1-8076-fc1c8ceae6fd 61 fields · synced Jul 18, 2026
  • EUDAMED 6829a89f-e43d-4380-a7bb-03230cd6a120 61 fields · synced Jul 19, 2026
  • EUDAMED a399aa7f-327a-4982-a8b8-428c089c608c 61 fields · synced Jul 20, 2026
  • EUDAMED 573eae50-1b84-4083-a038-b5aa61a4344d 61 fields · synced Jul 21, 2026
  • EUDAMED fb58fc8a-64a7-429b-a3a9-44c27c0f640f 61 fields · synced Jul 22, 2026
  • EUDAMED 29f1483a-8e5a-4e16-9e8e-4fe88f744f7b 61 fields · synced Jul 23, 2026
  • EUDAMED 2ab45331-d678-4d86-9f4e-87ed9cb102b4 61 fields · synced Jul 24, 2026
  • EUDAMED 99a836b9-9d7c-435c-935c-39795b4d7a91 61 fields · synced Jul 24, 2026
  • EUDAMED 480bbe71-031e-4412-b3bb-c15af8c1c818 61 fields · synced Jul 26, 2026
  • EUDAMED 807ba62f-73b9-40de-b413-b58b68336e4b 61 fields · synced Jul 29, 2026
  • EUDAMED df172ea2-cd6e-4116-a8fc-8a0a7dde8b05 61 fields · synced Jul 30, 2026
  • EUDAMED 37c0a9d3-4a24-48de-a6ff-b9346e6d7bfb 61 fields · synced Jul 30, 2026
  • EUDAMED 6d5c4139-bb48-412d-899c-2ebf5ad179cd 61 fields · synced Jul 30, 2026
  • EUDAMED a9444cd5-6640-49c2-a6d4-f214a8555a08 61 fields · synced Jul 30, 2026
  • EUDAMED 29c2e057-277e-4420-add8-e5cbf6183e05 61 fields · synced Jul 30, 2026
  • EUDAMED e171100a-5aae-46b8-891d-b2a4215bf3d3 61 fields · synced Aug 2, 2026
  • EUDAMED 443bd872-0ec6-4209-8f4b-4a34471f8196 61 fields · synced Aug 4, 2026
  • EUDAMED 3fba857f-81ed-4f51-b6f8-46b381f3dc55 61 fields · synced Aug 4, 2026
  • EUDAMED ae0e27f7-c8f5-48b0-95b1-355ac98bcb1d 61 fields · synced Aug 4, 2026
  • EUDAMED e6db479a-b71d-469d-91ca-7e74f9005798 61 fields · synced Sep 18, 2026
  • EUDAMED 1257461e-b990-4a18-a7a8-d7159a732a12 61 fields · synced Sep 18, 2026