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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 / June 2026 / K261068

510(k) cleared

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)

Serpex Medical · Jun 30, 2026 · K261068 · In the directory

FDA cleared the Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) from Serpex Medical on Jun 30, 2026 under K261068, a traditional 510(k). The device falls under product code GEH, Unit, Cryosurgical, Accessories, regulated at 21 CFR 878.4350 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Apr 1, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Serpex Medical has one other decision in the tracker over the last 12 months: K262420 (Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)).

Questions & Answers

What did FDA clear under K261068?

K261068 is the FDA 510(k) for Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000), submitted by Serpex Medical. FDA's decision date was Jun 30, 2026, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)?

Serpex Medical, based in Santa Clara, CA, is the applicant of record for K261068. The company is listed in the MedDevice Startups directory.

How long did the K261068 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Jun 30, 2026, 90 days later.

← All decisions in June 2026

Sources

In the startup directory

Maverix Medical

Respiratory & Sleep · Menlo Park, CA