Skip to content

Evicel Application Device

by Omrix Biopharmaceuticals, Ltd. 2 variants

510(k) K070575

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK070575 Date29 May 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1534-2018 FDA Class II initiated 7 Mar 2018

    Products labeled for distribution outside the United States may have been distributed to customers in the United States.

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  • Withdrawn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
FDA applicant
Omrix Biopharmaceuticals , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Omrix Biopharmaceuticals, Ltd.