510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905495Substantially Equivalent

Hysteromat Hysteroflator Hysteroscopic Insufflator

Frigitronics, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905495 is the FDA 510(k) clearance record for HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR, a class II device, cleared for Frigitronics, Inc. on under FDA product code HIG (Insufflator, Hysteroscopic). FDA records list 3 510(k) clearances for Frigitronics, Inc., from to . As of , FDA records show no recalls naming K905495.

Clearance record

Decision date
Received
(143 days to decision)
Product code
HIG Insufflator, Hysteroscopic
Regulation
21 CFR 884.1700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Frigitronics, Inc. 1963 Rock St., Mountain View CA
Third party review
No

Clearances, product code HIG

Trailing 12 months
2 clearances under product code HIG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260