Device, Thermal Ablation, Endometrial
FDA product code MNB · Class III (high risk) · Obstetrics/Gynecology
0510(k) clearances
9PMA approvals
10recalls
PMA approvals
- P230002 Minitouch 3.8 Era System (Minitouch System) · Microcube, LLC · 07/28/2023
- P180032 Cerene® Cryotherapy Device · Channel Medsystems, Inc. · 03/28/2019
- P160047 MARA Vapor System, MARA Vapor Probe Procedure Kit, MARA Vapor Generator and MARA Vapor Generator Accessory Kit · CooperSurgical, Inc. · 06/14/2017
- P140013 Minerva Endometrial Ablation System · Axora Medical, Inc. · 07/27/2015
- P020031 Microsulis Microwave Endometrial Ablation (Mea) System · Microsulis Medical , Ltd. · 09/23/2003
- P010013 Novasure Impedance Controlled Endometrial Ablation System · Hologic, Inc. · 09/28/2001
- P000040 Hydro Thermablator Endometrial Ablation System · Axora Medical, Inc. · 04/20/2001
- P000032 Her Option (TM) Uterine Cryoblation Therapy System · CooperSurgical, Inc. · 04/20/2001
- P970021 Thermachoice Uterine Balloon Therapy(Ubt) System · Gynecare, Inc. · 12/12/1997
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1584-2025 Class II | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION…Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of… | Channel Medsystems, Inc. | 03/20/2025Open, Classified |
| Z-1889-2024 Class II | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION…Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section… | Channel Medsystems, Inc. | 05/03/2024Open, Classified |
| Z-1094-2014 Class II | NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller…NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, | Hologic, Inc | 01/24/2014Terminated |
| Z-2209-2009 | Boston Scientific HydroThermAblator Endometrial Ablation System- HTA System Procedure…Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks… | Boston Scientific Corporation | 07/31/2009Terminated |
| Z-2208-2009 | Boston Scientific HydroThermAblator Endometrial Ablation System- HTA Procedure Set…Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks… | Boston Scientific Corporation | 07/31/2009Terminated |
| Z-0691-2007 | HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | Boston Scientific Corporation | 01/24/2007Terminated |
| Z-0690-2007 | HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | Boston Scientific Corporation | 01/24/2007Terminated |
| Z-0689-2007 | HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | Boston Scientific Corporation | 01/24/2007Terminated |
| Z-0688-2007 | HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | Boston Scientific Corporation | 01/24/2007Terminated |
| Z-0687-2007 | HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled…Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90… | Boston Scientific Corporation | 01/24/2007Terminated |