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Data / Medical devices / United States / Axora Medical, Inc.

Axora Medical, Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 5 510(k) clearances and 2 PMA approvals

Axora Medical, Inc. is registered with the FDA (registration 3043236281) in Sunnyvale, CA, United States. It lists 7 device types. The FDA files 5 510(k) clearances and 2 PMA approvals under its listings, the newest dated August 18, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Axora Medical, Inc.
FDA registration number
3043236281
Address
1000 Hamlin Ct, Sunnyvale, CA, United States, 94089
Owner or operator
Axora Medical, Inc. (10095231)
Roles
Complaint file establishment, Specification developer
First device listed
February 9, 2026
Registered through
2027
Brand names listed
HERizon RD5 Resecting Device

Devices it lists

DeviceProduct codeClassRoleSource
Device, Thermal Ablation, EndometrialMNB3Complaint file establishment, Specification developeraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Complaint file establishment, Specification developeraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Complaint file establishment, Specification developeraccessdata.fda.gov
Insufflator, HysteroscopicHIG2Complaint file establishment, Specification developeraccessdata.fda.gov
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, BipolarPGT2Complaint file establishment, Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 18, 2026K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIHSubstantially EquivalentAxora Medical, Inc.accessdata.fda.gov
January 17, 2024K233710Symphion Operative Hysteroscopy SystemPGTSubstantially EquivalentMinerva Surgical, Inc.accessdata.fda.gov
January 16, 2020K191538Resectr Tissue Resection DeviceHIHSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 14, 2016K160751Symphion Endoscope and Symphion Cervical SheathHIHSubstantially EquivalentBoston Scientificaccessdata.fda.gov
August 29, 2014K141848IOGYN SYSTEMPGTSubstantially EquivalentIogyn, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
July 27, 2015P140013MINERVA ENDOMETRIAL ABLATION SYSTEMMNB17February 12, 2026accessdata.fda.gov
April 20, 2001P000040HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEMMNB42May 26, 2022accessdata.fda.gov

Compare with other makers

Updated August 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.