CryOmega 160-2002

• FDA 510(k) K102006 decided 6 Oct 2010 Active
• FDA GUDID UDI-DI 00850077006210 listed 27 Jan 2020 Listed

1. 6 Oct 2010 Cleared FDA 510(k) K102006
2. 27 Jan 2020 Listed FDA GUDID 00850077006210

Trade name

CryOmega

Generic name

Cryogenic spray, cutaneous

Model / Ref / Catalog

160-2002

Primary DI / UDI-DI

00850077006210

510(k) Number

K102006 ↗

FDA product code

GEH

GMDN term

Cryogenic spray, cutaneous

Device class

Class II

Regulation number

878.4350

GUDID distribution status

In Commercial Distribution

Size

Weight — 16 Gram

Category: Cryogenic spray, cutaneous

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

• CRYOPEN AND ACCESSORIES by Cimex Biotech, LLC
• Co-Ablation System with Sterile Co-Ablation Probe by Hygea Medical Technology Co., Ltd.
• CANDELA CRYO-PROBE HOLDER by Candela Laser Corp.
• DEEP FREEZE SYSTEM (DFS-30) by Spembly Medical, Ltd.
• SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA by GALIL MEDICAL LTD
• CRYONIZE TM by 3jt Enterprises, LLC
• ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM by ENDOCARE, INC.
• Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) by Medical Brands Laboratories B.V.
• CryoFreeze Wart and Skin Tag Remover by Cryosurgery, Inc.
• SANARUS VISICA TREATMENT SYSTEM by Sanarus Medical, Inc.

• Histofreezer 1001-0294

  Class II

  FDA 510(k) K990877 Active Cleared 14 Jun 1999 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

• Histofreezer 1001-0295

  Class II

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

See all devices from Cryoconcepts, LP →