510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951946Substantially Equivalent

Hysterosys Flexible Hysterocope

Ovamed Corp., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951946 is the FDA 510(k) clearance record for HYSTEROSYS FLEXIBLE HYSTEROCOPE, a class II device, cleared for Ovamed Corp. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 5 510(k) clearances for Ovamed Corp., from to . As of , FDA records show no recalls naming K951946.

Clearance record

Decision date
Received
(208 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ovamed Corp. 760 San Aleso Ave., Sunnyvale CA
510(k) summary
Statement
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