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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 / October 2025 / K253226

510(k) cleared

UV5000W Handle

Uroviu Corporation · Oct 23, 2025 · K253226

FDA cleared the UV5000W Handle from Uroviu Corporation on Oct 23, 2025 under K253226, a special 510(k). The device falls under product code FAJ, Cystoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 29, 2025. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Uroviu Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253226?

K253226 is the FDA 510(k) for UV5000W Handle, submitted by Uroviu Corporation. FDA's decision date was Oct 23, 2025, under product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Who makes the UV5000W Handle?

Uroviu Corporation, based in Los Altos, CA, is the applicant of record for K253226.

How long did the K253226 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Oct 23, 2025, 24 days later.

← All decisions in October 2025