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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / August 2026 / K260984

510(k) cleared

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)

Axora Medical, Inc. · Aug 18, 2026 · K260984 · In the directory

FDA cleared the HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) from Axora Medical, Inc. on Aug 18, 2026 under K260984, a traditional 510(k). The device falls under product code HIH, Hysteroscope (And Accessories), regulated at 21 CFR 884.1690 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Mar 25, 2026. The decision came 146 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Axora Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260984?

K260984 is the FDA 510(k) for HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK), submitted by Axora Medical, Inc.. FDA's decision date was Aug 18, 2026, under product code HIH (Hysteroscope (And Accessories)).

Who makes the HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)?

Axora Medical, Inc., based in Jacksonville, FL, is the applicant of record for K260984. The company is listed in the MedDevice Startups directory.

How long did the K260984 review take?

FDA received the submission on Mar 25, 2026 and issued its decision on Aug 18, 2026, 146 days later.

← All decisions in August 2026

Sources

In the startup directory

Axora Medical

Women's Health · Sunnyvale, CA