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Wallach 906043-40TU

by CooperSurgical, Inc.

Wallach 906043-40TU is a colposcope (FDA Class II; FDA product code DRC, Trocar) made by CooperSurgical, Inc., cleared under FDA 510(k) K853389 on 19 Nov 1985 and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 00888937013726), 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) K853389

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 Number00888937013726 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK853389 Date19 Nov 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K853389 decided 19 Nov 1985 Active
  • FDA GUDID UDI-DI 00888937013726 listed 18 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K853389
  2. Listed FDA GUDID 00888937013726

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Wallach
Generic name
Colposcope
Model / reference
906043-40TU
Primary DI / UDI-DI
00888937013726
510(k) Number
FDA product code
DRC
GMDN term
Colposcope
Device class
Class II
Regulation number
870.1390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Colposcope

Cleared under the same submission (K853389)

and 3 more cleared under K853389

Similar devices

Other devices filed under FDA product code DRC (Trocar).

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)