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Reveal 00711775

by US Endoscopy

Part of a family of 6 devices: see the family page

Ref 00711775Model Reveal Distal Attachment Cap

Reveal 00711775 is a device classified as Class IIa in the EU and Class II in the US made by US Endoscopy, registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI 0724995ENREVLDISATHCPFV), cleared under FDA 510(k) K140315 on 4 Apr 2014 and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 00724995184780), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140315

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995ENREVLDISATHCPFV Basic UDI-DI 00724995184780UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995184780 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140315 Date4 Apr 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995ENREVLDISATHCPFV registered 8 Oct 2026 Active
  • FDA 510(k) K140315 decided 4 Apr 2014 Active
  • FDA GUDID UDI-DI 00724995184780 listed 1 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140315
  2. Listed FDA GUDID 00724995184780
  3. Registered EUDAMED 0724995ENREVLDISATHCPFV

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  • Withdrawn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
Reveal
Generic name
Endoscope tissue removal cap, single-use
Model / Ref / Catalog
00711775, Reveal Distal Attachment Cap
Primary DI / UDI-DI
00724995184780
Basic UDI-DI
0724995ENREVLDISATHCPFV
510(k) Number
FDA product code
OCX
EMDN code
Z12021199 Orthopaedic endoscopy instruments - other
GMDN term
Endoscope tissue removal cap, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 16 Millimeter

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: Endoscope tissue removal cap, single-use

Cleared under the same submission (K140315)

and 1 more cleared under K140315

Similar devices in this category

Other devices filed under ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER.

Other devices from US Endoscopy

See all devices from US Endoscopy →

Properties

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