ClearanceBrief
Panels › General, Plastic Surgery › Product code GEH · Class 2

Unit, Cryosurgical, Accessories

Regulation 878.4350

10510(k)s in 12 months (265 all time)
5recalls in 12 months (107 all time)
87recalls that name a 510(k)
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Top companies in GEH

Company510(k)sRecalls
Boston Scientific553
Galil Medical , Ltd.297
CSA Medical, Inc.142
Endocare, Inc.131
Cooper Surgical, Inc.013
AtriCure, Inc.83
C2 Therapeutics81
Cryoconcepts LP90
Cryomedical Sciences, Inc.90
OraSure Technologies, Inc.63
DateFirm and productCodeLinked 510(k)
Sep 3, 2008Galil Medical
Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue.
Terminated		 GEHK012497
Jul 11, 2007Wallach Surgical Devices, Inc.
Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
Terminated		 GEHK803311
Jul 11, 2007Wallach Surgical Devices, Inc.
Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218
Terminated		 GEHK803311
Oct 28, 2006ATS Medical, Inc.
CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) pa
Terminated		 GEHK053436
Nov 20, 2004Premier Dental Products Co
Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument
Terminated		 GEHK970992
Nov 20, 2004Premier Dental Products Co
Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument
Terminated		 GEHK970992
Apr 16, 2003Endocare Inc
SurgiFrost Cryosurgical Probes
Terminated		 GEHNone listed

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