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286005334N

by Medos International Sàrl

286005334N is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K233254 on 14 Jun 2024 (1 earlier submission) and listed in FDA GUDID since 9 Aug 2022 (UDI-DI 10705034548890), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233254 Date14 Jun 2024DecidedStatusActive
United StatesGUDID listing Number10705034548890 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233254 decided 14 Jun 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705034548890 listed 9 Aug 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212756
  2. Listed FDA GUDID 10705034548890
  3. Cleared FDA 510(k) K233254

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Bone curette, reusable
Model / Ref / Catalog
286005334N
Primary DI / UDI-DI
10705034548890
510(k) Number
FDA product code
OLO
GMDN term
Bone curette, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)