510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K190194Substantially Equivalent

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Pentax Medical, A Division of Pentax of America, Inc., Redwood, Ca CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190194 is the FDA 510(k) clearance record for C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge, a class II device, cleared for Pentax Medical, A Division of Pentax of America, Inc. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 2 510(k) clearances for Pentax Medical, A Division of Pentax of America, Inc., from to . As of , FDA records show no recalls naming K190194.

Clearance record

Decision date
Received
(116 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Pentax Medical, A Division of Pentax of America, Inc. 303 Convention Way, Suite 1, Redwood, Ca CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260