Skip to content

Harvest Graft Delivery Syringe

by Harvest Technologies, Corp.

510(k) K043261

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043261 Date11 Mar 2005ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0075-2018 FDA Class II initiated 20 Oct 2017

    Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.

    • Terminated Z-0022-2014 FDA Class II initiated 11 Sep 2013

    Potential for leur connector to leak or have cracks.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Harvest Technologies, Corp.

See all devices from Harvest Technologies, Corp. →