Cool Renewal

510(k) Number

K161296 ↗

FDA product code

GEH

Device class

Class II

Regulation

21 CFR Part 878.4350

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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).

• Advanced Cryo Wart Remover by Medical Brands Laboratories B.V.
• Skin Clinic Freeze Point for Warts and Skin Tags by CRYOCONCEPTS, LP
• truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 by STERIS CORPORATION
• CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit by NUANCE MEDICAL, LLC
• MODEL GT1ST CRYOSURGICAL INSTRUMENT by Gyne-Tech Instrument Corp.
• Erbe 20402-501 by Erbe Elektromedizin GmbH
• WA1000 by Wallach Surgical Devices, Inc.
• CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 by Cryomedical Sciences, Inc.
• cryoFORM cryoICE cryoablation probe by ATRICURE, INC.
• CMS URETHRAL WARMER by Cryomedical Sciences, Inc.

• Cool Renewal Cr-RC1

  Class II

  FDA 510(k) K161296 Active Cleared 6 Jul 2016 GUDID on market

• Cool Renewal Cr-K

  Class II

  FDA 510(k) K161296 Active Cleared 6 Jul 2016 GUDID on market

• Cool Renewal Cr-Rc

  Class II

  FDA 510(k) K161296 Active Cleared 6 Jul 2016 GUDID on market

• Cool Renewal Cr-K1

  Class II

  FDA 510(k) K161296 Active Cleared 6 Jul 2016 GUDID on market