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Reusable Laparoscopic Instruments

by Snowden-Pencer

510(k) K930667

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

15 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 NumberK930667 Date16 May 1994ClearedStatusActive

Recalls

15 recalls · 15 ongoing · FDA

  • 15 recalls, same reason

    • Ongoing Z-2427-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2429-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2428-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2415-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2422-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2425-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2426-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2419-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2420-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2418-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2424-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2423-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2421-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2416-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2417-2023 FDA Class II initiated 13 Jul 2023

    Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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