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Stabilisation disc 195 200 260BC

by SOPRO-COMEG GmbH

Stabilisation disc 195 200 260BC is a Class II device made by SOPRO-COMEG GmbH, cleared under FDA 510(k) K971881 on 12 Aug 1997 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 04059082009483), 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) K971881

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 Number04059082009483 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK971881 Date12 Aug 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K971881 decided 12 Aug 1997 Active
  • FDA GUDID UDI-DI 04059082009483 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K971881
  2. Listed FDA GUDID 04059082009483

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stabilisation disc
Generic name
Endoscopic irrigation/aspiration pump
Model / reference
195 200 260BC
Primary DI / UDI-DI
04059082009483
510(k) Number
FDA product code
FDC
GMDN term
Endoscopic irrigation/aspiration pump
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscopic irrigation/aspiration pump

Cleared under the same submission (K971881)

and 8 more cleared under K971881

Similar devices

Other devices filed under FDA product code FDC (RESECTOSCOPE, WORKING ELEMENT).

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)