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Co-Axial Introducer Needle

by Promex, Inc.

510(k) K022634

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022634 Date6 Nov 2002ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1074-2021 FDA Class II initiated 10 Dec 2020
    • Terminated Z-1077-2021 FDA Class II initiated 10 Dec 2020
    • Terminated Z-1072-2021 FDA Class II initiated 10 Dec 2020
    • Terminated Z-1076-2021 FDA Class II initiated 10 Dec 2020
    • Terminated Z-1075-2021 FDA Class II initiated 10 Dec 2020
    • Terminated Z-1073-2021 FDA Class II initiated 10 Dec 2020

    Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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