510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961605Substantially Equivalent

Karl Storz 10.5 Fr. Flexible Hysteroscope

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961605 is the FDA 510(k) clearance record for KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show one recall naming K961605.

Clearance record

Decision date
Received
(202 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260