# P000040: Hydro Thermablator Endometrial Ablation System

- Pathway: PMA
- Applicant: Axora Medical, Inc.
- Decided: Apr 20, 2001 after 207 days
- Product code: MNB (Device, Thermal Ablation, Endometrial)
- Device class: 3
- Recalls of this device: 8 (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
- Jul 31, 2009 · Not classified · Z-2209-2009: Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.
- Jul 31, 2009 · Not classified · Z-2208-2009: Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.
- Jan 24, 2007 · Not classified · Z-0687-2007: Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
- Jan 24, 2007 · Not classified · Z-0689-2007: Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
- Jan 24, 2007 · Not classified · Z-0690-2007: Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
- Jan 24, 2007 · Not classified · Z-0688-2007: Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
- Jan 24, 2007 · Not classified · Z-0691-2007: Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
- Jul 28, 2005 · Not classified · Z-1020-05: The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.

Source page: https://510kreport.com/device/P000040
Methodology: https://510kreport.com/methodology