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Perfuse Decompression Instrumentation 800-0546

by Biomet Biologics, LLC

Perfuse Decompression Instrumentation 800-0546 is an instrument tray (FDA Class II; FDA product code FMF, Syringe, piston) made by Biomet Biologics, LLC, cleared under FDA 510(k) K141762 on 27 Aug 2014 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00880304680333), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K141762

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 Number00880304680333 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141762 Date27 Aug 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141762 decided 27 Aug 2014 Active
  • FDA GUDID UDI-DI 00880304680333 listed 3 Nov 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1814-2016 FDA Class II initiated 11 Apr 2016

    The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.

Timeline

3 dated events

  1. Cleared FDA 510(k) K141762
  2. Recall initiated FDA recalls Z-1814-2016
  3. Listed FDA GUDID 00880304680333

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Perfuse Decompression Instrumentation
Generic name
Instrument tray, reusable
Model / Ref / Catalog
800-0546
Primary DI / UDI-DI
00880304680333
510(k) Number
FDA product code
FMF
GMDN term
Instrument tray, reusable
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K141762)

and 8 more cleared under K141762

Similar devices in this category

Other devices filed under Instrument tray, reusable.

Other devices from Biomet Biologics, LLC

See all devices from Biomet Biologics, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)