510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022445Substantially Equivalent

Visera Hysterovideoscope Olympus Hyf Type V

Olympus Optical Co., Ltd., Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022445 is the FDA 510(k) clearance record for VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V, a class II device, cleared for Olympus Optical Co., Ltd. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 48 510(k) clearances for Olympus Optical Co., Ltd., from to . As of , FDA records show one recall naming K022445.

Clearance record

Decision date
Received
(183 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Olympus Optical Co., Ltd. Two Corporate Center Dr., Melville NY
510(k) summary
Summary PDF
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