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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 / February 2026 / K260287

510(k) cleared

SP Electrocautery Device (SP20)

Single Pass, Inc. · Feb 24, 2026 · K260287

FDA cleared the SP Electrocautery Device (SP20) from Single Pass, Inc. on Feb 24, 2026 under K260287, a special 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 29, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Single Pass, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260287?

K260287 is the FDA 510(k) for SP Electrocautery Device (SP20), submitted by Single Pass, Inc.. FDA's decision date was Feb 24, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the SP Electrocautery Device (SP20)?

Single Pass, Inc., based in Lake Forest, CA, is the applicant of record for K260287.

How long did the K260287 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Feb 24, 2026, 26 days later.

← All decisions in February 2026