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Ethicon ESS15

by Ethicon Inc.

Ref ESS15

Ethicon ESS15 is a device classified as Class I in the EU and Class II in the US made by Ethicon Inc., registered in EUDAMED on 15 May 2026 (Basic UDI-DI 0705031a000013K), cleared under FDA 510(k) K963329 on 25 Oct 1996 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705031148161), active as of 23 Oct 2026.

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

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K963329

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705031a000013K Basic UDI-DI 10705031148161UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031148161 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK963329 Date25 Oct 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705031a000013K registered 15 May 2026 Active
  • FDA 510(k) K963329 decided 25 Oct 1996 Active
  • FDA GUDID UDI-DI 10705031148161 listed 24 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K963329
  2. Listed FDA GUDID 10705031148161
  3. Registered EUDAMED 0705031a000013K

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  • Withdrawn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
Endosuture System Endo-Holder EUDAMED
Ethicon GUDID
Generic name
Suture/ligature tightener, reusable
Model / Ref / Catalog
ESS15
Primary DI / UDI-DI
10705031148161
Basic UDI-DI
0705031a000013K
510(k) Number
FDA product code
GCJ
EMDN code
L0299 Suture instruments, reusable - other
GMDN term
Suture/ligature tightener, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Suture/ligature tightener, reusable

Similar devices in this category

Other devices filed under SUTURE INSTRUMENTS, REUSABLE - OTHER.

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)