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Echelon Linear

by Ethicon Endo-Surgery, LLC 2 variants

Ref GLC60

Echelon Linear (GLC60) is an open-surgery manual linear cutting stapler (EU MDR Class IIa; FDA Class II) made by Ethicon Endo-Surgery, LLC, registered in EUDAMED on 30 Sep 2025 (Basic UDI-DI 0705036a000897G), cleared under FDA 510(k) K223760 on 15 Mar 2023 and listed in FDA GUDID since 15 Apr 2024 (UDI-DI 10705036030874), active as of 22 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223760

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705036a000897G Basic UDI-DI 10705036030874UDI-DIDate30 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705036030874 UDI-DI Date15 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223760 Date15 Mar 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705036a000897G registered 30 Sep 2025 Active
  • FDA 510(k) K223760 decided 15 Mar 2023 Active
  • FDA GUDID UDI-DI 10705036030874 listed 15 Apr 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0147-2026 FDA Class II initiated 11 Sep 2025

    The devices were shipped unsterilized.

Timeline

4 dated events

  1. Cleared FDA 510(k) K223760
  2. Listed FDA GUDID 10705036030874
  3. Recall initiated FDA recalls Z-0147-2026
  4. Registered EUDAMED 0705036a000897G

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Echelon Linear EUDAMED
Echelon Linear Cutter GUDID
Generic name
Open-surgery manual linear cutting stapler, single-use
Model / Ref / Catalog
GLC60
Primary DI / UDI-DI
10705036030874
Basic UDI-DI
0705036a000897G
510(k) Number
FDA product code
GDW, GAG
EMDN code
H020201010101 Single patient straight linear staplers with blade for open surgery
GMDN term
Open-surgery manual linear cutting stapler, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4750, 878.4740
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 IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
US-MF-000013107
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Related devices

Category: Open-surgery manual linear cutting stapler, single-use

Similar devices in this category

Other devices filed under SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY.

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)