510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212814Substantially Equivalent

C2 CryoBalloon Ablation System

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

K212814 is the FDA 510(k) clearance record for C2 CryoBalloon Ablation System, a class II device, cleared for Pentax of America, Inc. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 72 510(k) clearances for Pentax of America, Inc., from to . As of , FDA records show no recalls naming K212814.

Clearance record

Decision date
Received
(87 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 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