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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 / K261139

510(k) cleared

VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)

Freyja Healthcare, LLC · Aug 13, 2026 · K261139

FDA cleared the VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) from Freyja Healthcare, LLC on Aug 13, 2026 under K261139, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 7, 2026. The decision came 128 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 Freyja Healthcare, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261139?

K261139 is the FDA 510(k) for VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103), submitted by Freyja Healthcare, LLC. FDA's decision date was Aug 13, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)?

Freyja Healthcare, LLC, based in Framingham, MA, is the applicant of record for K261139.

How long did the K261139 review take?

FDA received the submission on Apr 7, 2026 and issued its decision on Aug 13, 2026, 128 days later.

← All decisions in August 2026