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Bovie CS-105T-LED

by Aspen Surgical Products, Inc. 2 variants

Bovie CS-105T-LED, a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Aspen Surgical Products, Inc., was cleared under FDA 510(k) K073053 on 15 Nov 2007 and listed in FDA GUDID on 29 Aug 2016 (UDI-DI 10607151011328); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K073053

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 Number10607151011328 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK073053 Date15 Nov 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K073053 decided 15 Nov 2007 Active
  • FDA GUDID UDI-DI 10607151011328 listed 29 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K073053
  2. Listed FDA GUDID 10607151011328

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bovie
Generic name
Colposcope
Model / Ref / Catalog
CS-105T-LED
Primary DI / UDI-DI
10607151011328
510(k) Number
FDA product code
HEX
GMDN term
Colposcope
Device class
Class II
Regulation number
884.1630
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Colposcope

Cleared under the same submission (K073053)

and 8 more cleared under K073053

Similar devices

Other devices filed under FDA product code HEX (Colposcope (And Colpomicroscope)).

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Convenience kit
  • Serial number
Other properties (13, all answered No)