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Disposable Syringes and Disposable Needles

by Myco Medical Supplies Inc.

510(k) K945225

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 NumberK945225 Date26 Jan 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0444-2016 FDA Class II initiated 6 Nov 2015 on shared 510(k) K945225

    Particulates: Complaints of rubber coring from the closure of injection vials.

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  • Withdrawn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
FMF
FDA applicant
Myco Medical Supplies, Inc.
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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