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Mic Peg Tube

by Medical Innovations Corp.

510(k) K924065

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

12 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)SEKD Traditional NumberK924065 Date17 Feb 1994ClearedStatusActive

Recalls

14 recalls · 12 ongoing · FDA

  • 12 recalls, same reason

    • Ongoing Z-2343-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2348-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2346-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2344-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2352-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2347-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2349-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2342-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2350-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2345-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2351-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2341-2026 FDA Class II initiated 30 Apr 2026

    Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

  • 2 recalls, same reason

    • Terminated Z-0566-2022 FDA Class II initiated 22 Dec 2021
    • Terminated Z-0565-2022 FDA Class II initiated 22 Dec 2021

    The External Retention Bolster contained in the kit may be a larger diameter than the tube.

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  • Withdrawn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
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SEKD

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