Histofreezer 1001-0293

• FDA 510(k) K990877 decided 14 Jun 1999 Active
• FDA GUDID UDI-DI 00850077006081 listed 22 Sep 2020 Listed

1. 14 Jun 1999 Cleared FDA 510(k) K990877
2. 22 Sep 2020 Listed FDA GUDID 00850077006081

Trade name

Histofreezer

Generic name

General cryosurgical system, cryogen gas, mechanical

Model / Ref / Catalog

1001-0293, 40T1C

Primary DI / UDI-DI

00850077006081

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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• CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 by ENDOCARE, INC.
• SPRAYGENIX CRYO ABLATION SYSTEM by Crymed Technologies, Inc.
• MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM by ENDOCARE, 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 →