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Papette 908003-2

by CooperSurgical, Inc.

Papette 908003-2 is a Class II device made by CooperSurgical, Inc., cleared under FDA 510(k) K896065 on 4 Jan 1990 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 50888937011314), 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

510(k) K896065

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number50888937011314 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK896065 Date4 Jan 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K896065 decided 4 Jan 1990 Active
  • FDA GUDID UDI-DI 50888937011314 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K896065
  2. Listed FDA GUDID 50888937011314

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Papette
Generic name
Cervical cytology brush
Model / reference
908003-2
Primary DI / UDI-DI
50888937011314
510(k) Number
FDA product code
HHT
GMDN term
Cervical cytology brush
Device class
Class II
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cervical cytology brush

Cleared under the same submission (K896065)

and 2 more cleared under K896065

Similar devices in this category

Other devices filed under Cervical cytology brush.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)