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Piston Syringe

by Martell Medical Products, Inc.

510(k) K944941

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK944941 Date5 Dec 1994ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1779-2022 FDA Class II initiated 8 Sep 2022

    The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.

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  • Withdrawn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
CBT
Device Class
Class I
Regulation
21 CFR Part 868.1100
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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