# P000032: Her Option (TM) Uterine Cryoblation Therapy System

- Pathway: PMA
- Applicant: CooperSurgical, Inc.
- Decided: Apr 20, 2001 after 267 days
- Product code: MNB (Device, Thermal Ablation, Endometrial)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 13, 2006 · Not classified · Z-0675-06: Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.

Source page: https://510kreport.com/device/P000032
Methodology: https://510kreport.com/methodology