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Onpoint 24-3200

by Biomet Microfixation, Inc

Onpoint 24-3200 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K082293 on 9 Sep 2008 and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036130244), 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) K082293

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 Number00841036130244 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082293 Date9 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082293 decided 9 Sep 2008 Active
  • FDA GUDID UDI-DI 00841036130244 listed 11 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082293
  2. Listed FDA GUDID 00841036130244

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Onpoint
Generic name
Endoscopic video imaging system
Model / Ref / Catalog
24-3200
Primary DI / UDI-DI
00841036130244
510(k) Number
FDA product code
GCJ, HRX
GMDN term
Endoscopic video imaging system
Device class
Class II
Regulation number
876.1500, 888.1100
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscopic video imaging system

Cleared under the same submission (K082293)

and 6 more cleared under K082293

Similar devices

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

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

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