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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 / September 2025 / K252183

510(k) cleared

Resitu Slider 09 (RESL09)

Resitu Medical AB · Sep 24, 2025 · K252183

FDA cleared the Resitu Slider 09 (RESL09) from Resitu Medical AB on Sep 24, 2025 under K252183, a traditional 510(k). The device falls under product code KNW, Instrument, Biopsy, regulated at 21 CFR 876.1075 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 11, 2025. The decision came 75 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Resitu Medical AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252183?

K252183 is the FDA 510(k) for Resitu Slider 09 (RESL09), submitted by Resitu Medical AB. FDA's decision date was Sep 24, 2025, under product code KNW (Instrument, Biopsy).

Who makes the Resitu Slider 09 (RESL09)?

Resitu Medical AB, based in Uppsala, is the applicant of record for K252183.

How long did the K252183 review take?

FDA received the submission on Jul 11, 2025 and issued its decision on Sep 24, 2025, 75 days later.

← All decisions in September 2025