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Resectoscope Sheath

by Olympus Corp. 510(k)

Active United States Open recall

510(k) K931995

Regulatory status

as of 28 Oct 2026

Recall ongoing. 18 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931995 Date23 Jul 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

18 recalls · 18 ongoing · FDA

  • 18 recalls, same reason

    • Ongoing Z-1445-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1455-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1452-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1440-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1450-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1442-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1439-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1444-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1453-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1456-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1441-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1451-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1448-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1457-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1443-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1446-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1438-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1447-2026 FDA Class II initiated 11 Nov 2025

    Complaints of the ceramic tip of the resection sheath breaking have been received.

Specification

510(k)

510(k) Number
FDA Product Code
FJL
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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