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MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL 109582802

by Avanos Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

12 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00350770997896 UDI-DI Date20 Oct 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL
Generic Name
Gastrostomy tube
Model / Ref / Catalog
109582802, 0644-14
Primary DI / UDI-DI
00350770997896
510(k) Number
FDA Product Code
KNT
GMDN Term
Gastrostomy tube
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K924065)

Show all (12)

Other devices from Avanos Medical, Inc.

See all devices from Avanos Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No