Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043236281

FEI Number

3043236281

Entity Name

AXORA MEDICAL, INC.

City/State/Country

Jacksonville, FL, US

Establishment Address

1 Independent Dr, Jacksonville, FL 32202, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Axora Medical, Inc. (Owner Number: 10095231)

Owner / Operator Contact Address

1 Independent Drive, Jacksonville, FL 32202, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P000040

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	Obstetrics/Gynecology	Class 2	884.1710	2026-02-20
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	Obstetrics/Gynecology	Class 2	884.1710	2026-02-21
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2026-02-21
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2026-02-21
MNB	Device, Thermal Ablation, Endometrial	Unknown	Class 3	N/A	2026-02-21

Official Correspondent

Natalie Kennel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Axora Medical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905706	Circon Acmi	GYN-1500 HYSTEROSCOPIC INUFFLATOR	1991-02-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043236281. Last updated year: 2026. Please use registration number 3043236281 when referencing this establishment in official correspondence.