# MNB · Device, Thermal Ablation, Endometrial

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/OB-misc/MNB

## Overview

- **Product Code:** MNB
- **Device Name:** Device, Thermal Ablation, Endometrial
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P230002](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P230002.md) | Minitouch 3.8 Era System (Minitouch System) | Microcube, LLC | Jul 28, 2023 | APPR |
| [P180032](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P180032.md) | Cerene® Cryotherapy Device | Channel Medsystems, Inc. | Mar 28, 2019 | APPR |
| [P160047](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P160047.md) | MARA™ Vapor System, MARA™ Vapor Probe Procedure Kit, MARA™ Vapor Generator and MARA™ Vapor Generator Accessory Kit | CooperSurgical, Inc. | Jun 14, 2017 | APWD |
| [P140013](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P140013.md) | MINERVA ENDOMETRIAL ABLATION SYSTEM | Axora Medical, Inc. | Jul 27, 2015 | APPR |
| [P020031](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P020031.md) | MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM | Microsulis Medical , Ltd. | Sep 23, 2003 | APWD |
| [P010013](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P010013.md) | NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM | Hologic, Inc. | Sep 28, 2001 | APPR |
| [P000040](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P000040.md) | HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM | Axora Medical, Inc. | Apr 20, 2001 | APPR |
| [P000032](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P000032.md) | HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM | CooperSurgical, Inc. | Apr 20, 2001 | APWD |
| [P970021](https://fda.innolitics.com/submissions/OB/OB-misc/MNB/P970021.md) | THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM | Gynecare, Inc. | Dec 12, 1997 | APWD |

## Top Applicants

- Axora Medical, Inc. — 2 clearances
- CooperSurgical, Inc. — 2 clearances
- Channel Medsystems, Inc. — 1 clearance
- Gynecare, Inc. — 1 clearance
- Hologic, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OB/OB-misc/MNB](https://fda.innolitics.com/submissions/OB/OB-misc/MNB)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com