Home › Device types › MNB
Device, Thermal Ablation, Endometrial
FDA product code MNB · Class 3 · Unknown
42
Registered devices
6,312
Adverse events
12
Recalls
0
510(k) clearances
Devices with this code
Minerva Co2 Canisters — Minerva Surgical, Inc.Minitouch — Microcube, LLCMinitouch — Microcube, LLCMinitouch — Microcube, LLC815012US — Hologic, Inc.Mara Water Vapor Probe Kit — AEGEA MEDICAL INC.NovaSure SureSound — Hologic, Inc.Minitouch — Microcube, LLCMinitouch — Microcube, LLCExhaust Collection Bag — CHANNEL MEDSYSTEMS, INC.NovaSure — Hologic, Inc.Cerene Cryotherapy Device — CHANNEL MEDSYSTEMS, INC.Minitouch — Microcube, LLCGenesys HTA Control Unit — Minerva Surgical, Inc.Genesys HTA ProCerva — Minerva Surgical, Inc.NovaSure — Hologic, Inc.Genesys HTA System — BOSTON SCIENTIFIC CORPORATIONHer Option — Coopersurgical, Inc.GYNECARE THERMACHOICE — Ethicon Inc.Minerva Argon Gas Canister (5 pack) — Minerva Surgical, Inc.Minerva Single Sterile Disposable Handpiece — Minerva Surgical, Inc.Exhaust Collection Bag — CHANNEL MEDSYSTEMS, INC.Genesys HTA ProCerva — BOSTON SCIENTIFIC CORPORATIONNovaSure SureSound — Hologic, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-20 | Channel Medsystems, Inc. | Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment |
| 2024-05-03 | Channel Medsystems, Inc. | Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Code |
| 2014-01-24 | Hologic, Inc | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, |
| 2009-07-31 | Boston Scientific Corporation | Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for |
| 2009-07-31 | Boston Scientific Corporation | Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for |
| 2007-01-24 | Boston Scientific Corporation | Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recircula |
| 2007-01-24 | Boston Scientific Corporation | Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recircula |
| 2007-01-24 | Boston Scientific Corporation | Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recircula |
| 2007-01-24 | Boston Scientific Corporation | Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recircula |
| 2007-01-24 | Boston Scientific Corporation | Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recircula |
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