510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881349Substantially Equivalent

Verruca-Freeze(tm) Cryotherapy Delivery System

Cryosurg, Inc., Nashville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881349 is the FDA 510(k) clearance record for VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM, a class II device, cleared for Cryosurg, Inc. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list one 510(k) clearance for Cryosurg, Inc. As of , FDA records show no recalls naming K881349.

Clearance record

Decision date
Received
(92 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cryosurg, Inc. 7356 Cabot Dr., Nashville TN
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