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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 / October 2025 / K252640

510(k) cleared

VereSee Optical Veres Needle and Endoscopic Camera

Freyja Healthcare, LLC · Oct 20, 2025 · K252640

FDA cleared the VereSee Optical Veres Needle and Endoscopic Camera from Freyja Healthcare, LLC on Oct 20, 2025 under K252640, 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 Aug 21, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Freyja Healthcare, LLC has one other decision in the tracker over the last 12 months: K261139 (VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)).

Questions & Answers

What did FDA clear under K252640?

K252640 is the FDA 510(k) for VereSee Optical Veres Needle and Endoscopic Camera, submitted by Freyja Healthcare, LLC. FDA's decision date was Oct 20, 2025, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the VereSee Optical Veres Needle and Endoscopic Camera?

Freyja Healthcare, LLC, based in Boston, MA, is the applicant of record for K252640.

How long did the K252640 review take?

FDA received the submission on Aug 21, 2025 and issued its decision on Oct 20, 2025, 60 days later.

← All decisions in October 2025

Sources