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Karl Storz 10.5 Fr. Flexible Hysteroscope

by Karl Storz Endoscopy-America, Inc.

510(k) K961605

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 NumberK961605 Date13 Nov 1996ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2794-2026 FDA Class II initiated 21 May 2026

    Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

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  • Withdrawn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
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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