510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931534Substantially Equivalent

Ovamed Intrauterine Access Catheter

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

K931534 is the FDA 510(k) clearance record for OVAMED INTRAUTERINE ACCESS CATHETER, a class II device, cleared for Ovamed Corp. on under FDA product code MOV (Catheters, Salpingography). FDA records list 5 510(k) clearances for Ovamed Corp., from to . As of , FDA records show no recalls naming K931534.

Clearance record

Decision date
Received
(851 days to decision)
Product code
MOV Catheters, Salpingography
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ovamed Corp. 111 W. Evelyn Ave.,, Sunnyvale CA
510(k) summary
Statement
Third party review
No

Clearances, product code MOV

Trailing 12 months

FDA records hold no clearances under product code MOV in the trailing twelve months.

FDA records show no clearances under product code MOV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MOV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260