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Genesys HTA System

by Axora Medical, Inc. PMA

Active United States

PMA P000040

Overview

The Genesys HTA System is a thermal ablation device designed to ablate the endometrial lining of the uterus. It is indicated for use in premenopausal women suffering from menorrhagia, or excessive uterine bleeding, caused by benign conditions where childbearing is complete.

This system is authorized under FDA PMA P000040. It is intended for clinical use by medical professionals to address specific gynecological health needs in patients who have finished childbearing.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP000040 Date20 Apr 2001ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

8 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2208-2009 FDA Unclassified (pre-2012) initiated 31 Jul 2009
    • Terminated Z-2209-2009 FDA Unclassified (pre-2012) initiated 31 Jul 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.

  • 5 recalls, same reason

    • Terminated Z-0688-2007 FDA Unclassified (pre-2012) initiated 24 Jan 2007
    • Terminated Z-0689-2007 FDA Unclassified (pre-2012) initiated 24 Jan 2007
    • Terminated Z-0691-2007 FDA Unclassified (pre-2012) initiated 24 Jan 2007
    • Terminated Z-0687-2007 FDA Unclassified (pre-2012) initiated 24 Jan 2007
    • Terminated Z-0690-2007 FDA Unclassified (pre-2012) initiated 24 Jan 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

    • Terminated Z-1020-05 FDA Unclassified (pre-2012) initiated 28 Jul 2005

    The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.

Specification

PMA

Trade Name
Hydro Thermablator Endometrial Ablation System
Generic Name
Device, thermal ablation, endometrial
PMA Number
FDA Product Code
MNB
Device Class
Class III
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APPR Approved

Other devices from Axora Medical, Inc.

Questions

  • What is the primary purpose of the Genesys HTA System?

    The system is a thermal ablation device intended to ablate the endometrial lining of the uterus to treat menorrhagia, which is excessive uterine bleeding caused by benign conditions.

  • Who is the intended patient for this device?

    The device is intended for premenopausal women who experience menorrhagia due to benign causes and for whom childbearing is complete.

  • Is the Genesys HTA System FDA authorized?

    Yes, the device is authorized under FDA PMA number P000040.