Skip to content

Safetex 890076

by Andwin Scientific

Safetex 890076 is a cervical cytology scraper (FDA Class II; FDA product code HHT, Spatula, Cervical, Cytological) made by Andwin Scientific, cleared under FDA 510(k) K983428 on 16 Nov 1998 and listed in FDA GUDID since 1 Nov 2017 (UDI-DI 00187207000238), 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) K983428

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 Number00187207000238 UDI-DI Date1 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983428 Date16 Nov 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983428 decided 16 Nov 1998 Active
  • FDA GUDID UDI-DI 00187207000238 listed 1 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983428
  2. Listed FDA GUDID 00187207000238

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Safetex
Generic name
Cervical cytology scraper, single-use
Model / reference
890076
Primary DI / UDI-DI
00187207000238
510(k) Number
FDA product code
HHT
GMDN term
Cervical cytology scraper, single-use
Device class
Class II
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cervical cytology scraper, single-use

Cleared under the same submission (K983428)

Similar devices

Other devices filed under FDA product code HHT (Spatula, Cervical, Cytological).

Other devices from Andwin Scientific

See all devices from Andwin Scientific →

Properties

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