CryoTouch

510(k) Number

K183601 ↗

FDA product code

GEH

FDA applicant

Cryoconcepts LP

Device class

Class II

Regulation

21 CFR Part 878.4350

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

• IceSense 3, ProSense, MultiSense by ICECURE MEDICAL LTD.
• UTERMOHLEN CRYO PROFESSIONAL by Koninklijke (Royal) Utermohlen
• Cool Renewal by Cool Renewal, LLC
• Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel by GALIL MEDICAL LTD
• C2 Cryoballoon Ablation System by C2 THERAPEUTICS, INC.
• POLAR WAND by Chek-Med Systems
• truFreeze System by CSA Medical
• HISTOFREEZER VERRUCA PLANA by OraSure Technologies, Inc.
• Cryocare CS-3 Surgical System version 5 by HealthTronics, LLC
• CRYOPROBES MC-1400-CRYOSURG-CONSOLE by Spembly Medical, Ltd.

• Histofreezer 1001-0294

  Class II

  FDA 510(k) K990877 Active Cleared 14 Jun 1999 GUDID on market

• CryOmega 160-2002

  Class II

  FDA 510(k) K102006 Active Cleared 6 Oct 2010 GUDID on market

• Histofreezer FLEX 200-3050

  Class II

  FDA 510(k) K183601 Active Cleared 18 Apr 2019 GUDID on market

• CryoClear 161-2001

  Class II

  FDA 510(k) K102006 Active Cleared 6 Oct 2010 GUDID on market

See all devices from Cryoconcepts, LP →