Product code MNB
- Device name
- Device, Thermal Ablation, Endometrial
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P140013S018 | Minerva Endometrial Ablation System | Axora Medical, Inc. | 2026-02-12 |
| P180032S022 | Cerene® Cryotherapy Device | Channel Medsystems, Inc. | 2025-12-18 |
| P010013S094 | NovaSure Model 10 RF Controller | Hologic, Inc. | 2025-12-17 |
| P140013S016 | Minerva Endometrial Ablation System | Axora Medical, Inc. | 2025-04-14 |
| P160047S039 | Mara Water Vapor Ablation System | CooperSurgical, Inc. | 2025-01-07 |
| P180032S020 | Cerene Cryotherapy Device | Channel Medsystems, Inc. | 2024-12-12 |
| P140013S017 | Minerva ES Endometrial Ablation System | Axora Medical, Inc. | 2024-12-05 |
| P180032S019 | Cerene Cryotherapy Device | Channel Medsystems, Inc. | 2024-11-22 |
| P180032S021 | Cerene Cryotherapy Device | Channel Medsystems, Inc. | 2024-10-17 |
| P010013S093 | NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. | 2024-09-06 |
| P010013S092 | NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. | 2024-07-23 |
| P180032S018 | Cerene Cryotherapy Device | Channel Medsystems, Inc. | 2024-07-17 |
| P230002S001 | Minitouch 3.8 Era System (Minitouch System) | Microcube, LLC | 2024-07-16 |
| P160047S035 | MARA Water Vapor Ablation System | CooperSurgical, Inc. | 2024-07-11 |
| P160047S038 | MARA Water Vapor Ablation System | CooperSurgical, Inc. | 2024-07-09 |
| P160047S036 | MARA Water Vapor Ablation System | CooperSurgical, Inc. | 2024-05-10 |
| P180032S016 | Cerene Cryotherapy Device (Model Number FGS-7000) | Channel Medsystems, Inc. | 2024-04-11 |
| P140013S015 | Minerva Endometrial Ablation System | Axora Medical, Inc. | 2024-01-24 |
| P140013S014 | Minerva Endometrial Ablation System | Axora Medical, Inc. | 2023-12-18 |
| P160047S034 | Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode | CooperSurgical, Inc. | 2023-12-08 |
| P180032S015 | Cerene® Cryotherapy Device | Channel Medsystems, Inc. | 2023-11-16 |
| P180032S014 | Cerene® Cryotherapy Device | Channel Medsystems, Inc. | 2023-11-14 |
| P010013S091 | NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. | 2023-10-27 |
| P160047S033 | MARA Water Vapor Ablation System | CooperSurgical, Inc. | 2023-10-25 |
| P010013S090 | NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. | 2023-09-22 |
| P230002 | Minitouch 3.8 Era System (Minitouch System) | Microcube, LLC | 2023-07-28 |
| P160047S031 | Mara Water Vapor Ablation System | CooperSurgical, Inc. | 2023-07-28 |
| P160047S032 | Mara Water Vapor Ablation System | CooperSurgical, Inc. | 2023-07-27 |
| P180032S013 | Cerene Cryotherapy Device | Channel Medsystems, Inc. | 2023-07-17 |
| P160047S030 | Mara Water Vapor Ablation System | CooperSurgical, Inc. | 2023-06-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888937026870 | Mara Console | Coopersurgical, Inc. | 2024-03-13 |
| 00888937026887 | Mara | Coopersurgical, Inc. | 2023-12-01 |
| 10850044503015 | Minitouch | Microcube, LLC | 2023-10-18 |
| 00850044503209 | Minitouch | Microcube, LLC | 2023-10-18 |
| 00850044503162 | Minitouch | Microcube, LLC | 2023-10-18 |
| 00850044503155 | Minitouch | Microcube, LLC | 2023-10-18 |
| 00850044503018 | Minitouch | Microcube, LLC | 2023-10-18 |
| 00850044503117 | Minitouch | Microcube, LLC | 2023-10-18 |
| 00850044503124 | Minitouch | Microcube, LLC | 2023-10-18 |
| 00850044503131 | Minitouch | Microcube, LLC | 2023-10-18 |
| 00850044503148 | Minitouch | Microcube, LLC | 2023-10-18 |
| 15420045515154 | NovaSure | Hologic, Inc. | 2023-04-22 |
| 00850008595042 | Exhaust Collection Bag | CHANNEL MEDSYSTEMS, INC. | 2023-04-06 |
| 00850033976014 | Genesys HTA Control Unit | Minerva Surgical, Inc. | 2022-06-08 |
| 00850033976021 | Genesys HTA Control Unit - Refurbished | Minerva Surgical, Inc. | 2022-06-08 |
| 00850033976038 | Genesys HTA ProCerva | Minerva Surgical, Inc. | 2022-06-08 |
| 15420045514294 | NovaSure | Hologic, Inc. | 2021-07-02 |
| 15420045514300 | NovaSure | Hologic, Inc. | 2021-07-02 |
| 25420045514307 | NovaSure | Hologic, Inc. | 2021-07-02 |
| 00850008595028 | Exhaust Collection Bag | CHANNEL MEDSYSTEMS, INC. | 2020-08-21 |
| 20850008595022 | Exhaust Collection Bag | CHANNEL MEDSYSTEMS, INC. | 2020-08-21 |
| 00850008595035 | Cerene Cryotherapy Device | CHANNEL MEDSYSTEMS, INC. | 2020-08-21 |
| 08714729809463 | Genesys HTA ProCerva | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 08714729809456 | Genesys HTA ProCerva | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 20705031050737 | GYNECARE THERMACHOICE | ETHICON INC. | 2014-09-20 |
| 10705031000865 | GYNECARE THERMACHOICE | Ethicon Inc. | 2014-09-20 |
| 20705031050744 | GYNECARE THERMACHOICE | Ethicon Inc. | 2014-09-20 |
| 20705031000886 | GYNECARE THERMACHOICE | Ethicon Inc. | 2014-09-20 |
| 10705031050730 | GYNECARE THERMACHOICE | Ethicon Inc. | 2014-09-20 |
| 00888937000016 | Her Option | Coopersurgical, Inc. | 2014-09-17 |