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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 / K251566

510(k) cleared

TS-RF Generator (STS10)

Starmed Co., Ltd. · Nov 17, 2025 · K251566

FDA cleared the TS-RF Generator (STS10) from Starmed Co., Ltd. on Nov 17, 2025 under K251566, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on May 22, 2025. The decision came 179 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Starmed Co., Ltd. has one other decision in the tracker over the last 12 months: K252833 (VIVA combo RF System).

Questions & Answers

What did FDA clear under K251566?

K251566 is the FDA 510(k) for TS-RF Generator (STS10), submitted by Starmed Co., Ltd.. FDA's decision date was Nov 17, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the TS-RF Generator (STS10)?

Starmed Co., Ltd., based in Goyang-Si, is the applicant of record for K251566.

How long did the K251566 review take?

FDA received the submission on May 22, 2025 and issued its decision on Nov 17, 2025, 179 days later.

← All decisions in November 2025

Sources