CryoLab

510(k) Number

K190407 ↗

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

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).

• SPEMBLY MEDICAL 142 CRYO UNIT by Spembly Medical, Ltd.
• CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 by New Medical Technologies GmbH
• Coldplay CryoBalloon® Ablation System by C2 THERAPEUTICS, INC.
• Compound W Wart Removal System Dual Power by MEDTECH PRODUCTS, INC.
• HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS by OraSure Technologies, Inc.
• DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 by Schering-Plough Healthcare Products, Inc.
• ERBE 20402-410 by Erbe Elektromedizin GmbH
• HISTOFREEZER by Solarcare Technologies Corp, Inc.
• SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) by GALIL MEDICAL LTD
• FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE by Cryocath Technologies, Inc.

• 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 →