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Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets

by Cook Incorporated

510(k) K173035

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 NumberK173035 Date1 May 2018ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-1786-2026 FDA Class II initiated 5 Mar 2026

    Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  • 2 recalls, same reason

    • Ongoing Z-2223-2024 FDA Class II initiated 15 May 2024
    • Ongoing Z-2222-2024 FDA Class II initiated 15 May 2024

    Product labels state the incorrect expiration dates that extends beyond their true expiration date

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  • Withdrawn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
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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