# P180032: Cerene® Cryotherapy Device

- Pathway: PMA
- Applicant: Channel Medsystems, Inc.
- Decided: Mar 28, 2019 after 227 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
- Mar 20, 2025 · Class II · Z-1584-2025: 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 during venting of the device

Source page: https://510kreport.com/device/P180032
Methodology: https://510kreport.com/methodology