WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K251813

510(k) cleared

CURIS II RF Generator (REF 360100-05)

Sutter Medizintechnik GmbH · Feb 11, 2026 · K251813

FDA cleared the CURIS II RF Generator (REF 360100-05) from Sutter Medizintechnik GmbH on Feb 11, 2026 under K251813, 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 Jun 13, 2025. The decision came 243 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 Sutter Medizintechnik GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251813?

K251813 is the FDA 510(k) for CURIS II RF Generator (REF 360100-05), submitted by Sutter Medizintechnik GmbH. FDA's decision date was Feb 11, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the CURIS II RF Generator (REF 360100-05)?

Sutter Medizintechnik GmbH, based in Emmendingen, is the applicant of record for K251813.

How long did the K251813 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Feb 11, 2026, 243 days later.

← All decisions in February 2026