Chrysalis Intelligence · Sponsors · Axora Medical, Inc.

Axora Medical, Inc.

Jacksonville, FL, US · 1 510(k) clearances · 13 PMAs

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Total clearances
1
2026-08-18 → 2026-08-18
Last 12 months
1
Product codes
1
Most recent
2026-08-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HIH Hysteroscope (And Accessories) Class II Obstetrics/Gynecology 1 2026-08-18
Class III

PMA approvals (13)

Total PMA records
13
Originals + supplements
Distinct product codes
1
First decision
2020-02-12
Most recent
2026-02-12
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-02-12 P140013-S018 Minerva Endometrial Ablation System 30-Day Notice MNB Device, Thermal Ablation, Endometrial Unknown
2025-04-14 P140013-S016 Minerva Endometrial Ablation System Normal 180 Day Track No User Fee MNB Device, Thermal Ablation, Endometrial Unknown
2024-12-05 P140013-S017 Minerva ES Endometrial Ablation System Special (Immediate Track) MNB Device, Thermal Ablation, Endometrial Unknown
2024-01-24 P140013-S015 Minerva Endometrial Ablation System Special (Immediate Track) MNB Device, Thermal Ablation, Endometrial Unknown
2023-12-18 P140013-S014 Minerva Endometrial Ablation System Real-Time Process MNB Device, Thermal Ablation, Endometrial Unknown
2022-05-26 P000040-S042 Genesys HTA System Normal 180 Day Track No User Fee MNB Device, Thermal Ablation, Endometrial Unknown
2022-01-11 P140013-S013 Minerva® Endometrial Ablation System 30-Day Notice MNB Device, Thermal Ablation, Endometrial Unknown
2021-06-17 P000040-S041 Minerva Genesys HTA Endometrial Ablation System Normal 180 Day Track No User Fee MNB Device, Thermal Ablation, Endometrial Unknown
2021-02-17 P140013-S012 Minerva Endometrial Ablation System Real-Time Process MNB Device, Thermal Ablation, Endometrial Unknown
2020-12-17 P000040-S040 Hydro Thermablator Endometrial Ablation System 30-Day Notice MNB Device, Thermal Ablation, Endometrial Unknown
2020-07-30 P000040-S039 Hydro Thermablator Endometrial Ablation System 30-Day Notice MNB Device, Thermal Ablation, Endometrial Unknown
2020-05-19 P000040-S038 Hydro Thermablator Endometrial Ablation System Normal 180 Day Track No User Fee MNB Device, Thermal Ablation, Endometrial Unknown
2020-02-12 P140013-S011 Minerva Endometrial Ablation System Normal 180 Day Track No User Fee MNB Device, Thermal Ablation, Endometrial Unknown
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2026-08-18 K260984 HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) HIH Class II Obstetrics/Gynecology
Data source: openFDA · Generated 2026-09-08 09:57 · Last ingest 2026-09-08T13:56:10.065722 · Pipeline: Chrysalis Intelligence