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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 / September 2025 / K252530

510(k) cleared

OptiVu Shoulder

Mr Surgical Solutions, LLC · Sep 10, 2025 · K252530

FDA cleared the OptiVu Shoulder from Mr Surgical Solutions, LLC on Sep 10, 2025 under K252530, a special 510(k). The device falls under product code SBF, Orthopedic Augmented Reality, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 11, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Mr Surgical Solutions, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252530?

K252530 is the FDA 510(k) for OptiVu Shoulder, submitted by Mr Surgical Solutions, LLC. FDA's decision date was Sep 10, 2025, under product code SBF (Orthopedic Augmented Reality).

Who makes the OptiVu Shoulder?

Mr Surgical Solutions, LLC, based in Conshohocken, PA, is the applicant of record for K252530.

How long did the K252530 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Sep 10, 2025, 30 days later.

← All decisions in September 2025