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Echelon Endopath GST45B

by Ethicon Endo-Surgery, LLC

Part of a family of 16 devices: see the family page

Ref GST45BModel ECHELON

Echelon Endopath GST45B is a device classified as Class IIb in the EU and Class II in the US made by Ethicon Endo-Surgery, LLC, registered in EUDAMED on 20 Nov 2025 (Basic UDI-DI 0705036a000556X) and listed in FDA GUDID since 22 Feb 2017 (UDI-DI 10705036014881), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705036a000556X Basic UDI-DI 10705036014881UDI-DIDate20 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705036014881 UDI-DI Date22 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0705036a000556X registered 20 Nov 2025 Active
  • FDA GUDID UDI-DI 10705036014881 listed 22 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10705036014881
  2. Registered EUDAMED 0705036a000556X

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Echelon Endopath
Generic name
Surgical staple loading unit, non-cutting
Device name
ECHELON ENDOPATH Reloads (non-vascular)
Model / Ref / Catalog
GST45B, ECHELON
Primary DI / UDI-DI
10705036014881
Basic UDI-DI
0705036a000556X
FDA product code
GDW
EMDN code
H02030106 Linear stapler cartridges for videosurgery
GMDN term
Surgical staple loading unit, non-cutting
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4750
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical staple loading unit, non-cutting

Similar devices in this category

Other devices filed under LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY.

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)