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Andwin Scientific 890184

by Andwin Scientific

Andwin Scientific 890184 is a cervical cytology brush (FDA Class II; FDA product code HHT, Spatula, Cervical, Cytological) made by Andwin Scientific, cleared under FDA 510(k) K924908 on 13 Apr 1993 and listed in FDA GUDID since 22 May 2019 (UDI-DI 20187207000393), 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) K924908

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 Number20187207000393 UDI-DI Date22 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESK from GUDID Substantially Equivalent — Kit · Traditional NumberK924908 Date13 Apr 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K924908 decided 13 Apr 1993 Active
  • FDA GUDID UDI-DI 20187207000393 listed 22 May 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K924908
  2. Listed FDA GUDID 20187207000393

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Andwin Scientific
Generic name
Cervical cytology brush
Model / reference
890184
Primary DI / UDI-DI
20187207000393
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 (K924908)

and 5 more cleared under K924908

Similar devices in this category

Other devices filed under Cervical cytology brush.

Other devices from Andwin Scientific

See all devices from Andwin Scientific →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)