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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 / K250275

510(k) cleared

PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch

Baylis Medical Technologies, Inc. · Oct 28, 2025 · K250275

FDA cleared the PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch from Baylis Medical Technologies, Inc. on Oct 28, 2025 under K250275, 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 Jan 31, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Baylis Medical Technologies, Inc. has 2 other decisions in the tracker over the last 12 months: K254114 (Baylis Connector Cable), K251158 (PowerWire® 14 Radiofrequency Guidewire Kit).

Questions & Answers

What did FDA clear under K250275?

K250275 is the FDA 510(k) for PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch, submitted by Baylis Medical Technologies, Inc.. FDA's decision date was Oct 28, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch?

Baylis Medical Technologies, Inc., based in Mississauga, is the applicant of record for K250275.

How long did the K250275 review take?

FDA received the submission on Jan 31, 2025 and issued its decision on Oct 28, 2025, 270 days later.

← All decisions in October 2025

Sources