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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 / June 2026 / K261522

510(k) cleared

BioWave BioWraps

Biowave Corporation · Jun 3, 2026 · K261522

FDA cleared the BioWave BioWraps from Biowave Corporation on Jun 3, 2026 under K261522, a special 510(k). The device falls under product code GXY, Electrode, Cutaneous, regulated at 21 CFR 882.1320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 7, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Biowave Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261522?

K261522 is the FDA 510(k) for BioWave BioWraps, submitted by Biowave Corporation. FDA's decision date was Jun 3, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the BioWave BioWraps?

Biowave Corporation, based in Westport, CT, is the applicant of record for K261522.

How long did the K261522 review take?

FDA received the submission on May 7, 2026 and issued its decision on Jun 3, 2026, 27 days later.

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