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Ring applicator 191 060 341

by SOPRO-COMEG GmbH

Ring applicator 191 060 341 is a vaginal applicator (FDA Class II; FDA product code GCJ, Laparoscope, general & plastic surgery) made by SOPRO-COMEG GmbH, cleared under FDA 510(k) K945266 on 23 Feb 1995 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 04059082005065), 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) K945266

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 Number04059082005065 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK945266 Date23 Feb 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K945266 decided 23 Feb 1995 Active
  • FDA GUDID UDI-DI 04059082005065 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K945266
  2. Listed FDA GUDID 04059082005065

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ring applicator
Generic name
Vaginal applicator, reusable
Model / reference
191 060 341
Primary DI / UDI-DI
04059082005065
510(k) Number
FDA product code
GCJ
GMDN term
Vaginal applicator, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Vaginal applicator, reusable

Cleared under the same submission (K945266)

and 8 more cleared under K945266

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, general & plastic surgery).

Other devices from SOPRO-COMEG GmbH

See all devices from SOPRO-COMEG GmbH →

Properties

  • Sterilise before use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)