Histofreezer 1001-0295

• FDA 510(k) K990877 decided 14 Jun 1999 Active
• FDA GUDID UDI-DI 00850077006104 listed 22 Sep 2020 Listed

1. 14 Jun 1999 Cleared FDA 510(k) K990877
2. 22 Sep 2020 Listed FDA GUDID 00850077006104

Trade name

Histofreezer

Generic name

General cryosurgical system, cryogen gas, mechanical

Model / Ref / Catalog

1001-0295, 36M1C

Primary DI / UDI-DI

00850077006104

510(k) Number

K990877 ↗

FDA product code

GEH

GMDN term

General cryosurgical system, cryogen gas, mechanical

Device class

Class II

Regulation number

878.4350

GUDID distribution status

In Commercial Distribution

Category: General cryosurgical system, cryogen gas, mechanical

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• C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge by PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC
• Cryo-Hit Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1 by GALIL MEDICAL LTD
• CRYOBALLOON ABLATION SYSTEM by C2 THERAPEUTICS, INC.
• CRYOCARE CS SURGICAL SYSTEM by ENDOCARE, INC.
• Medi-Frig Cryosurgical Unit by Ellman Intl., Inc.
• LM 1000 Cryosurgical Accessories by Leisegang Medical, 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 →