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Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy Device - Lumbar

by Gallini Medical Devices, Srl

510(k) K141557

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK141557 Date8 Dec 2014ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0145-2022 FDA Class II initiated 17 May 2021
    • Terminated Z-0144-2022 FDA Class II initiated 17 May 2021
    • Terminated Z-0146-2022 FDA Class II initiated 17 May 2021

    The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent