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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 / November 2025 / K252287

510(k) cleared

Symani Surgical System

Medical Microinstruments, Inc. · Nov 10, 2025 · K252287

FDA cleared the Symani Surgical System from Medical Microinstruments, Inc. on Nov 10, 2025 under K252287, a traditional 510(k). The device falls under product code SAQ, Electromechanical System For Open Microsurgery, regulated at 21 CFR 878.4963 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 23, 2025. The decision came 110 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 Medical Microinstruments, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252287?

K252287 is the FDA 510(k) for Symani Surgical System, submitted by Medical Microinstruments, Inc.. FDA's decision date was Nov 10, 2025, under product code SAQ (Electromechanical System For Open Microsurgery).

Who makes the Symani Surgical System?

Medical Microinstruments, Inc., based in Pisa, is the applicant of record for K252287.

How long did the K252287 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Nov 10, 2025, 110 days later.

← All decisions in November 2025