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Corpak Percutaneous Endoscopic Gastrostomy Tube

by Corpak Co.

510(k) K882867

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 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)SESE Substantially Equivalent · Traditional NumberK882867 Date21 Sep 1988ClearedStatusActive

Recalls

14 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-2337-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2338-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2334-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2335-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2339-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2336-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2333-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2340-2026 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.

    • Terminated Z-1822-2020 FDA Class II initiated 16 Mar 2020 on shared 510(k) K882867

    The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.

  • 2 recalls, same reason

    • Terminated Z-0370-2020 FDA Class II initiated 8 Oct 2019
    • Terminated Z-0371-2020 FDA Class II initiated 8 Oct 2019

    The connector piece to the PEG tube does not pass over the guidewire.

  • 3 recalls, same reason

    • Terminated Z-2162-2017 FDA Class II initiated 3 Feb 2017
    • Terminated Z-2163-2017 FDA Class II initiated 3 Feb 2017
    • Terminated Z-2161-2017 FDA Class II initiated 3 Feb 2017

    Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.

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  • Withdrawn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

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