Histofreezer FLEX 200-6080

• FDA 510(k) K183601 decided 18 Apr 2019 Active
• FDA GUDID UDI-DI 00850077006371 listed 13 Sep 2020 Listed

1. 18 Apr 2019 Cleared FDA 510(k) K183601
2. 13 Sep 2020 Listed FDA GUDID 00850077006371

Trade name

Histofreezer FLEX

Generic name

General cryosurgical system, cryogen gas, mechanical

Model / Ref / Catalog

200-6080, 80SM

Primary DI / UDI-DI

00850077006371

510(k) Number

K183601 ↗

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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• CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 by Cryomedical Sciences, Inc.
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• PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS by PREMIER DENTAL PRODUCTS COMPANY

• 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 →