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ECS33B

by Ethicon Endo-Surgery, LLC

Ref ECS33B

ECS33B 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 23 Dec 2025 (Basic UDI-DI 0705036a000997K), cleared under FDA 510(k) K201280 on 27 Jul 2020 and listed in FDA GUDID since 20 Jan 2022 (UDI-DI 10705036022947), 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) K201280

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 Number0705036a000997K Basic UDI-DI 10705036022947UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705036022947 UDI-DI Date20 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK201280 Date27 Jul 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705036a000997K registered 23 Dec 2025 Active
  • FDA 510(k) K201280 decided 27 Jul 2020 Active
  • FDA GUDID UDI-DI 10705036022947 listed 20 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201280
  2. Listed FDA GUDID 10705036022947
  3. Registered EUDAMED 0705036a000997K

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  • Withdrawn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
Ethicon
Generic name
Intraluminal circular stapler, single-use
Device name
ETHICON Circular Stapler Sealed
Model / Ref / Catalog
ECS33B
Primary DI / UDI-DI
10705036022947
Basic UDI-DI
0705036a000997K
510(k) Number
FDA product code
GDW
EMDN code
H0203020101 Single-use curved circular staplers for videosurgery
GMDN term
Intraluminal circular stapler, single-use
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Intraluminal circular stapler, single-use

Similar devices in this category

Other devices filed under STAPLERS FOR VIDEOSURGERY.

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

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