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Endo-Boot 00711622

by US Endoscopy

Ref 00711622Model Endo Boot

Endo-Boot 00711622 is a device classified as Class I in the EU and Class II in the US made by US Endoscopy, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 0724995ENENDOBOOT64), cleared under FDA 510(k) K951104 on 6 Apr 1995 and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 10724995184022), 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, self-declared

Class I: no certifier involved

510(k) K951104

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 Number0724995ENENDOBOOT64 Basic UDI-DI 10724995184022UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10724995184022 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK951104 Date6 Apr 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995ENENDOBOOT64 registered 19 Aug 2026 Active
  • FDA 510(k) K951104 decided 6 Apr 1995 Active
  • FDA GUDID UDI-DI 10724995184022 listed 1 Apr 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K951104
  2. Listed FDA GUDID 10724995184022
  3. Registered EUDAMED 0724995ENENDOBOOT64

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  • Withdrawn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
Endo-Boot
Generic name
Surgical instrument guard, single-use
Model / Ref / Catalog
00711622, Endo Boot
Primary DI / UDI-DI
10724995184022
Basic UDI-DI
0724995ENENDOBOOT64
Unit of use DI
00724995184025
510(k) Number
FDA product code
OCU
EMDN code
T030102 Cover sheaths, instruments and equipments
GMDN term
Surgical instrument guard, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

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: Surgical instrument guard, single-use, sterile

Cleared under the same submission (K951104)

Similar devices in this category

Other devices filed under COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS.

Other devices from US Endoscopy

See all devices from US Endoscopy →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)