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Intraosseous Cannula System Bio-MAC¿ and Bio-CORE

by Biologic Therapies, Inc.

510(k) K141910

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 NumberK141910 Date4 May 2015ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1374-2015 FDA Class II initiated 23 Jan 2015 on shared 510(k) K141910
    • Terminated Z-1373-2015 FDA Class II initiated 23 Jan 2015 on shared 510(k) K141910

    Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent