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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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.

Freyja Healthcare, LLC has one other decision in the tracker over the last 12 months: K252640 (VereSee Optical Veres Needle and Endoscopic Camera).

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

Sources