Barrx CP-002A

Barrx CP-002A is a Class II device made by Covidien LP, cleared under FDA 510(k) K083711 on 2 Feb 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521189423), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10884521189423 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK083711	Date2 Feb 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10884521189423
FDA 510(k) database 510(k) number K083711

Across registries

2 registries list this device

FDA 510(k) K083711 decided 2 Feb 2009 Active
FDA GUDID UDI-DI 10884521189423 listed 24 Sep 2016 Listed

Timeline

2 dated events

2 Feb 2009 Cleared FDA 510(k) K083711
24 Sep 2016 Listed FDA GUDID 10884521189423

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Barrx
Generic name: Endoscope tissue removal cap, single-use
Model / reference: CP-002A

Primary DI / UDI-DI: 10884521189423
510(k) Number: K083711
FDA product code: GEI
GMDN term: Endoscope tissue removal cap, single-use

Device class: Class II
Regulation number: 878.4400
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)