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Barrx CP-001A

by Covidien LP

Ref CP-001A

Barrx CP-001A is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 0763000B00004577X), cleared under FDA 510(k) K083711 on 2 Feb 2009 and listed in FDA GUDID since 9 Nov 2024 (UDI-DI 10884521581852), 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) K083711

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 Number0763000B00004577X Basic UDI-DI 10884521581852UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521581852 UDI-DI Date9 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK083711 Date2 Feb 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00004577X registered 30 Sep 2026 Active
  • FDA 510(k) K083711 decided 2 Feb 2009 Active
  • FDA GUDID UDI-DI 10884521581852 listed 9 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083711
  2. Listed FDA GUDID 10884521581852
  3. Registered EUDAMED 0763000B00004577X

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  • Withdrawn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
Barrx
Generic name
Endoscope tissue removal cap, single-use
Device name
Barrx™ RFA Cleaning Cap, Small
Model / reference
CP-001A
Primary DI / UDI-DI
10884521581852
Basic UDI-DI
0763000B00004577X
510(k) Number
FDA product code
GEI
EMDN code
G99 Gastrointestinal devices - other
GMDN term
Endoscope tissue removal cap, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
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: Endoscope tissue removal cap, single-use

Cleared under the same submission (K083711)

Similar devices in this category

Other devices filed under GASTROINTESTINAL DEVICES - OTHER.

Other devices from Covidien LP

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    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

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