Her Option Uterine Cryoblation Therapy System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM FDA PMA
- Generic Name
- Device, thermal ablation, endometrial FDA PMA
Identifiers
- PMA Number
- P000032 FDA PMA
- FDA Product Code
- MNB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Obstetrics/Gynecology FDA PMA
- FDA Decision
- APWD FDA PMA
The Heroption Uterine Cryoablation Therapy System is a closed-cycle cryosurgical device classified as a thermal ablation instrument for endometrial treatment. It is designed to ablate the endometrial lining of the uterus in pre-menopausal women experiencing menorrhagia due to benign causes, where childbearing is complete.
This system is intended for use in clinical settings under appropriate medical supervision. It is supplied as a reusable device with specific regulatory approvals, including an FDA Premarket Approval (PMA). The device operates within a controlled cryogenic process and requires adherence to sterile procedures. No MRI safety information or additional size specifications are provided in the available data.
Frequently asked questions
What is the Heroption Uterine Cryoablation Therapy System used for in clinical practice?
The Heroption Uterine Cryoablation Therapy System is designed for endometrial ablation, specifically to treat excessive uterine bleeding (menorrhagia) in pre-menopausal women with benign causes. It is intended for patients who have completed childbearing and are seeking a non-hysterectomy alternative for symptom relief.
Is the Heroption System a single-use or reusable device, and what does that mean for clinical workflows?
The Heroption Uterine Cryoablation Therapy System is supplied as a reusable device, meaning it is intended for multiple procedures after proper cleaning, sterilization, and maintenance. This design allows for cost efficiency in clinical settings while ensuring adherence to sterile procedures during each use.
What regulatory pathway was followed for approval of this device, and how does that affect its availability?
The Heroption System received FDA Premarket Approval (PMA) under PMA number P000032, indicating a thorough review process for high-risk medical devices. This approval confirms its compliance with safety and effectiveness standards, ensuring its availability for use in clinical settings under appropriate medical supervision.
How should the Heroption System be handled in terms of sterility during procedures?
Since the Heroption System is a reusable device, it must be thoroughly cleaned and sterilized between uses to maintain sterility. Clinical staff should follow manufacturer-recommended protocols to ensure the device remains safe for cryosurgical endometrial ablation procedures.
Are there specific size or model variations available for the Heroption System, or is it a one-size-fits-all solution?
The provided data does not specify any size variations or distinct model numbers for the Heroption System, implying it is designed as a standardized reusable device for endometrial ablation. Clinicians should confirm compatibility with their patient population and procedural needs based on manufacturer guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P000032 | Class III | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA PMA P000032 24 fields · synced Sep 18, 2026