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)
Top companies in GEH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceFORCE" 2.1 CX Cryoablation Needle Completed |
GEH | K152133 |
| Nov 18, 2020 | Boston Scientific Corporation IceFORCE" 2.1 CX 90 Cryoablation Needle Completed |
GEH | K152133 |
| Sep 22, 2020 | Boston 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 |
GEH | K173037 |
| Jul 15, 2020 | OraSure 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 |
GEH | K023487 |
| Jul 15, 2020 | OraSure 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 |
GEH | K023487 |
| Jul 15, 2020 | OraSure 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 |
GEH | K023487 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Jun 4, 2020 | Boston 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 |
GEH | K152133 |
| Oct 25, 2019 | Galil 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 |
GEH | K113860 K123865 +1 |
| Dec 3, 2018 | PENTAX 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 |
GEH | K163684 |
| Dec 3, 2018 | PENTAX 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 |
GEH | K163684 |
| Dec 3, 2018 | PENTAX 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 |
GEH | K163684 |
| Dec 3, 2018 | PENTAX 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 |
GEH | K163684 |
| Jun 5, 2018 | PENTAX 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 |
GEH | K131523 |
| Mar 15, 2017 | C2 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 |
GEH | K131523 K152329 +1 |
| Apr 23, 2015 | CSA Medical CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device
Model: CC3-01 Terminated |
GEH | K143625 |
| Apr 16, 2015 | CooperSurgical, 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 |
GEH | K803311 |
| Jan 7, 2015 | CSA 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 |
GEH | K133258 |
| Dec 30, 2014 | Atricure 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 |
GEH | K082074 |
| Feb 15, 2013 | Healthtronics, 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 |
GEH | K101333 |
| Aug 23, 2012 | Galil 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 |
GEH | K113860 |
| May 16, 2012 | Galil 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 |
GEH | K060144 |
| Mar 21, 2012 | Healthtronics, 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 |
GEH | K101333 |
| Feb 3, 2011 | Galil 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 |
GEH | K021261 K051052 |
| Feb 3, 2011 | Galil 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 |
GEH | K060390 |
| Dec 29, 2010 | Galil 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 |
GEH | K010991 |
| Dec 13, 2010 | Endocare, 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 |
GEH | K060279 |
| Apr 16, 2010 | Endocare, 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 |
GEH | K011074 K023757 +1 |
| Apr 16, 2010 | Endocare, 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 |
GEH | K011074 K023757 +1 |
| Oct 29, 2009 | Cooper Surgical, Inc. WA 1000 A/B Console
Model: 900516x. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. WA 4000 Console
Model: 900509x. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. WA 1000A with Blank Console
Model: 900506x. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 System
Model: 900107. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer No Connector CO2 System
Model: 900047. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 System
Model: 900043. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer Atom CO2 System
Model: 900036. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System
Model: 900034. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer No Gas Fitting CO2 System
Model: 900019x. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL50x Cryosurgical Freezer CO2 Unpinned Yoke System
Model: 900010. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL50x Cryosurgical Freezer CO2 System
Model: 900007. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 System
Model: 9000002X. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2
Model: 900000. Terminated |
GEH | None listed |
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