Freezpen

• FDA 510(k) K024009 decided 20 Mar 2003 Active
• FDA GUDID UDI-DI B386CLFP000 listed 24 Sep 2016 Listed

1. 20 Mar 2003 Cleared FDA 510(k) K024009
2. 24 Sep 2016 Listed FDA GUDID B386CLFP000

Generic name

General cryosurgical system, cryogen gas, mechanical

Model / Ref / Catalog

Freezpen, CL-FP-00

Primary DI / UDI-DI

B386CLFP000

510(k) Number

K024009 ↗

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

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

• CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T by Brymill Corp.
• MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM, MODELS VS2000 by Sanarus Medical, Inc.
• ATRICURE CRYO1 CRYO-ABLATION PROBE by ATRICURE, INC.
• Urethral Warming Catheter Kit by Varian Medical Systems, Inc.
• truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 by STERIS CORPORATION
• VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM by Cryosurgery, Inc.
• cryoICE croablation probe by ATRICURE, INC.
• ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM by ENDOCARE, INC.
• SEEDNET, MODELS FP6T5, FP5T5, FP5T3 by GALIL MEDICAL LTD
• MT-700 MT-750 FT-350 by Cryomedics, Inc.

• CryoProbe™ CryoProbe|o 2018

  Class II

  FDA 510(k) K024009 Active Cleared 20 Mar 2003 GUDID on market

• Freezpen® 16g cartridges for Freezpen

  Class II

  FDA 510(k) K024009 Active Cleared 20 Mar 2003 GUDID on market

• Freezpen® Freezpen 8G

  Class II

  FDA 510(k) K024009 Active Cleared 20 Mar 2003 GUDID on market

• CryoProbe™ CryoProbe B+

  Class II

  FDA 510(k) K024009 Active Cleared 20 Mar 2003 GUDID on market

See all devices from H & O Equipments SA →