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Echelon Endopath
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref GCFLGTModel ECHELONRef GCFRGDRef GCFLGBRef GCFRGGRef GCFRGT510(k) K252906Ref ECR60WRef GCFRGB
Identity
- Trade Name
- Echelon Endopath EUDAMED
- Device Name
- ECHELON ENDOPATH Reloads (non-vascular) EUDAMED
- Model / Reference
- ECHELON EUDAMEDGCFLGT EUDAMEDGCFRGD EUDAMEDGCFLGB EUDAMEDGCFRGG EUDAMEDGCFRGT EUDAMEDECR60W EUDAMEDGCFRGB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705036023906 EUDAMED10705036023760 EUDAMED10705036023913 EUDAMED10705036023920 EUDAMED10705036023937 EUDAMEDD-USMF000013107000049MR EUDAMED10705036023753 EUDAMED
- Basic UDI-DI
- 0705036a000556X EUDAMEDB-USMF000013107000049MR EUDAMED
- 510(k) Number
- K252906 FDA 510(k)
- FDA Product Code
- OXC FDA 510(k)
- EMDN Code
- H02030106 LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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
Echelon Endopath by Ethicon Endo-Surgery, LLC — Class IIb — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0705036a000556X | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K252906 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0705036a000556X | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (8)
- EUDAMED 5214fd55-5d16-4713-9fe9-556996fef1c9 61 fields · synced Aug 3, 2026
- EUDAMED 07cd1cdd-29b7-4472-be41-15144c8d927e 61 fields · synced May 17, 2026
- EUDAMED 26706246-f6f5-4739-8e77-892f10612d29 61 fields · synced May 17, 2026
- EUDAMED e96ed930-80b3-457d-980c-93add8b0d577 61 fields · synced May 18, 2026
- EUDAMED 19d7837c-2a94-49e0-8a84-58655e7fe15d 61 fields · synced May 18, 2026
- FDA 510(k) K252906 24 fields · synced May 18, 2026
- EUDAMED 4f3a613d-e530-401a-8f8e-81b68629392a 61 fields · synced Jul 8, 2026
- EUDAMED 3add89a7-3219-4740-9d06-a8e6a236aa6d 61 fields · synced Jul 12, 2026