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

Unit, Cryosurgical, Accessories

Regulation 878.4350

9510(k)s in 12 months (264 all time)
5recalls in 12 months (107 all time)
87recalls that name a 510(k)
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Top companies in GEH

DateFirm and productCodeLinked 510(k)
Nov 18, 2020Boston Scientific Corporation
IceFORCE" 2.1 CX Cryoablation Needle
Completed
GEHK152133
Nov 18, 2020Boston Scientific Corporation
IceFORCE" 2.1 CX 90 Cryoablation Needle
Completed
GEHK152133
Sep 22, 2020Boston Scientific Corporation
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control an
Terminated
GEHK173037
Jul 15, 2020OraSure Technologies, Inc.
Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
Terminated
GEHK023487
Jul 15, 2020OraSure Technologies, Inc.
Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
Terminated
GEHK023487
Jul 15, 2020OraSure Technologies, Inc.
CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
Terminated
GEHK023487
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical pr
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical pr
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of t
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction o
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, IcePearl2.1 CX ProstateKit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgic
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surg
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgi
Terminated
GEHK152133
Jun 4, 2020Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical pro
Terminated
GEHK152133
Oct 25, 2019Galil Medical, Inc.
Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer
Terminated
GEHK113860
K123865 +1
Dec 3, 2018PENTAX of America Inc
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of
Terminated
GEHK163684
Dec 3, 2018PENTAX of America Inc
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general
Terminated
GEHK163684
Dec 3, 2018PENTAX of America Inc
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of gene
Terminated
GEHK163684
Dec 3, 2018PENTAX of America Inc
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifica
Terminated
GEHK163684
Jun 5, 2018PENTAX of America Inc
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Terminated
GEHK131523
Mar 15, 2017C2 Therapeutics, Inc.
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to
Terminated
GEHK131523
K152329 +1
Apr 23, 2015CSA Medical
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
Terminated
GEHK143625
Apr 16, 2015CooperSurgical, Inc.
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
Terminated
GEHK803311
Jan 7, 2015CSA Medical
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by
Terminated
GEHK133258
Dec 30, 2014Atricure Inc
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single u
Terminated
GEHK082074
Feb 15, 2013Healthtronics, Inc.
HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.
Terminated
GEHK101333
Aug 23, 2012Galil Medical, Inc.
Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedure
Terminated
GEHK113860
May 16, 2012Galil Medical, Inc.
Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medic
Terminated
GEHK060144
Mar 21, 2012Healthtronics, Inc.
CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissu
Terminated
GEHK101333
Feb 3, 2011Galil Medical, Inc.
SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblatio
Terminated
GEHK021261
K051052
Feb 3, 2011Galil Medical, Inc.
Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation syst
Terminated
GEHK060390
Dec 29, 2010Galil Medical
Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures whil
Terminated
GEHK010991
Dec 13, 2010Endocare, Division Of Healthtronics
Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
Terminated
GEHK060279
Apr 16, 2010Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.
V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Pro
Terminated
GEHK011074
K023757 +1
Apr 16, 2010Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.
V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryo
Terminated
GEHK011074
K023757 +1
Oct 29, 2009Cooper Surgical, Inc.
WA 1000 A/B Console Model: 900516x.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
WA 4000 Console Model: 900509x.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
WA 1000A with Blank Console Model: 900506x.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL100 Cryosurgical Freezer CO2 System Model: 900107.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL100 Cryosurgical Freezer No Connector CO2 System Model: 900047.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL100 Cryosurgical Freezer CO2 System Model: 900043.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL100 Cryosurgical Freezer Atom CO2 System Model: 900036.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System Model: 900034.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL100 Cryosurgical Freezer No Gas Fitting CO2 System Model: 900019x.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL50x Cryosurgical Freezer CO2 Unpinned Yoke System Model: 900010.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL50x Cryosurgical Freezer CO2 System Model: 900007.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL100 Cryosurgical Freezer CO2 System Model: 9000002X.
Terminated
GEHNone listed
Oct 29, 2009Cooper Surgical, Inc.
Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000.
Terminated
GEHNone listed

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