# P010013: Novasure Impedance Controlled Endometrial Ablation System

- Pathway: PMA
- Applicant: Hologic, Inc.
- Decided: Sep 28, 2001 after 212 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 24, 2014 · Class II · Z-1094-2014: NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,

Source page: https://510kreport.com/device/P010013
Methodology: https://510kreport.com/methodology