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Imc Hypodermic Needle

by International Medsurg Connection 510(k)

Active United States

510(k) K102584

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102584 Date14 Jan 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

20 recalls · FDA

  • 20 recalls, same reason

    • Terminated Z-2813-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2805-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2812-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2822-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2811-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2809-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2814-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2815-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2810-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2807-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2818-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2806-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2816-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2817-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2820-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2821-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2823-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2819-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2808-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2824-2017 FDA Class II initiated 23 Jun 2017

    Insufficient documentation to support product sterility claims.

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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