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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 / July 2026 / K262200

510(k) cleared

Stone Clear (BWSC-LP9-02)

Sonomotion, Inc. · Jul 29, 2026 · K262200

FDA cleared the Stone Clear (BWSC-LP9-02) from Sonomotion, Inc. on Jul 29, 2026 under K262200, a special 510(k). The device falls under product code QNA, Ultrasonic Urinary Stone Propulsion Device, regulated at 21 CFR 876.4690 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 29, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Sonomotion, Inc. has 2 other decisions in the tracker over the last 12 months: K261086 (Break Wave), K252913 (Break Wave).

Questions & Answers

What did FDA clear under K262200?

K262200 is the FDA 510(k) for Stone Clear (BWSC-LP9-02), submitted by Sonomotion, Inc.. FDA's decision date was Jul 29, 2026, under product code QNA (Ultrasonic Urinary Stone Propulsion Device).

Who makes the Stone Clear (BWSC-LP9-02)?

Sonomotion, Inc., based in San Mateo, CA, is the applicant of record for K262200.

How long did the K262200 review take?

FDA received the submission on Jun 29, 2026 and issued its decision on Jul 29, 2026, 30 days later.

← All decisions in July 2026

Sources