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Fms 283512

by Medos International Sàrl

Fms 283512 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K041824 on 7 Jan 2005 (1 earlier submission) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10886705016938), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886705016938 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041824 Date7 Jan 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041824 decided 7 Jan 2005 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10886705016938 listed 1 Sep 2015 Listed

Recalls

4 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0658-2016 FDA Class II initiated 20 Nov 2015
    • Terminated Z-0657-2016 FDA Class II initiated 20 Nov 2015
    • Terminated Z-0656-2016 FDA Class II initiated 20 Nov 2015

    Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

    • Terminated Z-0192-2014 FDA Class II initiated 29 Aug 2013

    Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination

Timeline

7 dated events

  1. Cleared FDA 510(k) K954465
  2. Cleared FDA 510(k) K041824
  3. Recall initiated FDA recalls Z-0192-2014
  4. Listed FDA GUDID 10886705016938
  5. Recall initiated FDA recalls Z-0658-2016
  6. Recall initiated FDA recalls Z-0657-2016
  7. Recall initiated FDA recalls Z-0656-2016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fms
Generic name
Arthroscopic shaver system, electrically-powered
Model / Ref / Catalog
283512
Primary DI / UDI-DI
10886705016938
510(k) Number
FDA product code
HRX
GMDN term
Arthroscopic shaver system, electrically-powered
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Arthroscopic shaver system, electrically-powered

Cleared under the same submission (K041824)

Cleared under the same submission (K954465)

and 8 more cleared under K954465

Similar devices

Other devices filed under FDA product code HRX (ARTHROSCOPE).

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)