510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K123865Substantially Equivalent

Visual-Ice Cryoablation System

Galil Medical Ltd., Fulshear TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123865 is the FDA 510(k) clearance record for VISUAL-ICE CRYOABLATION SYSTEM, a class II device, cleared for Galil Medical, Inc. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 31 510(k) clearances for Galil Medical, Inc., from to . As of , FDA records show one recall naming K123865.

Clearance record

Decision date
Received
(51 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Galil Medical, Inc. 6518 Tamarind Sky Ln., Fulshear TX
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