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En Bloc Biopsy System

by Neothermia Corp.

510(k) K003190

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 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 NumberK003190 Date11 Jun 2001ClearedStatusActive

Recalls

11 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-1132-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1130-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1129-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1126-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1133-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1136-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1134-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1127-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1131-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1135-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190
    • Terminated Z-1128-2017 FDA Class II initiated 28 Dec 2016 on shared 510(k) K003190

    Product sterility compromised due to breach of sterile barrier

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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