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Working element 196 010 010BC

by SOPRO-COMEG GmbH

Working element 196 010 010BC is a Class II device made by SOPRO-COMEG GmbH, cleared under FDA 510(k) K945262 on 26 May 1995 and listed in FDA GUDID since 22 Dec 2016 (UDI-DI 04059082009964), 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) K945262

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 Number04059082009964 UDI-DI Date22 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK945262 Date26 May 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K945262 decided 26 May 1995 Active
  • FDA GUDID UDI-DI 04059082009964 listed 22 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K945262
  2. Listed FDA GUDID 04059082009964

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Working element
Generic name
Endoscope assembly adaptor
Model / reference
196 010 010BC
Primary DI / UDI-DI
04059082009964
510(k) Number
FDA product code
FAJ
GMDN term
Endoscope assembly adaptor
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscope assembly adaptor

Cleared under the same submission (K945262)

and 8 more cleared under K945262

Similar devices

Other devices filed under FDA product code FAJ (Cystoscope and accessories, flexible/rigid).

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)