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Endosee System ES9000

by CooperSurgical, Inc.

Ref ES9000

Endosee System ES9000 is a device classified as Class IIa in the EU and Class II in the US made by CooperSurgical, Inc., registered in EUDAMED on 14 May 2026 (Basic UDI-DI 0888937TD008sYM), cleared under FDA 510(k) K183020 on 31 Jan 2019 and listed in FDA GUDID since 7 May 2019 (UDI-DI 00888937022018), active as of 23 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

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183020

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 Number0888937TD008sYM Basic UDI-DI 00888937022018UDI-DIDate14 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888937022018 UDI-DI Date7 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183020 Date31 Jan 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0888937TD008sYM registered 14 May 2026 Active
  • FDA 510(k) K183020 decided 31 Jan 2019 Active
  • FDA GUDID UDI-DI 00888937022018 listed 7 May 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-2112-2020 FDA Class II initiated 9 Apr 2020

    The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

Timeline

4 dated events

  1. Cleared FDA 510(k) K183020
  2. Listed FDA GUDID 00888937022018
  3. Recall initiated FDA recalls Z-2112-2020
  4. Registered EUDAMED 0888937TD008sYM

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  • Withdrawn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
Endosee® Advance System EUDAMED
Endosee System GUDID
Generic name
Flexible fibreoptic hysteroscope
Device name
Endosee Advance Display Module including all components
Model / reference
ES9000
Primary DI / UDI-DI
00888937022018
Basic UDI-DI
0888937TD008sYM
510(k) Number
FDA product code
FAJ, HIH
EMDN code
Z12020712 Video hysteroscopes
GMDN term
Flexible fibreoptic hysteroscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500, 884.1690
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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.

Related devices

Category: Flexible fibreoptic hysteroscope

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS.

Other devices from CooperSurgical, Inc.

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Properties

  • Reusable
  • Prescription use
  • Serial number
Other properties (22, all answered No)