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Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle

by Care Fusion

510(k) K171531

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK171531 Date11 Sep 2017ClearedStatusActive

Recalls

6 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2248-2021 FDA Class II initiated 23 Jun 2021
    • Ongoing Z-2247-2021 FDA Class II initiated 23 Jun 2021

    Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

  • 2 recalls, same reason

    • Terminated Z-0154-2022 FDA Class II initiated 24 Aug 2021
    • Terminated Z-0153-2022 FDA Class II initiated 24 Aug 2021

    Due to misbranded products shipped to customers.

    • Terminated Z-1689-2020 FDA Class II initiated 17 Mar 2020

    Sterility compromised due to packaging pouches that may not be sealed properly

    • Terminated Z-2411-2019 FDA Class II initiated 1 Aug 2019

    Product Pouches may not be sealed properly and compromise the sterility of the device

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  • Withdrawn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

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