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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 / July 2026 / K261632

510(k) cleared

Thunderbolt System

Responsive Arthroscopy, Inc. · Jul 20, 2026 · K261632

FDA cleared the Thunderbolt System from Responsive Arthroscopy, Inc. on Jul 20, 2026 under K261632, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 18, 2026. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

Responsive Arthroscopy, Inc. has one other decision in the tracker over the last 12 months: K253010 (Mini Superhawk Suture Anchor System).

Questions & Answers

What did FDA clear under K261632?

K261632 is the FDA 510(k) for Thunderbolt System, submitted by Responsive Arthroscopy, Inc.. FDA's decision date was Jul 20, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Thunderbolt System?

Responsive Arthroscopy, Inc., based in Minneapolis, MN, is the applicant of record for K261632.

How long did the K261632 review take?

FDA received the submission on May 18, 2026 and issued its decision on Jul 20, 2026, 63 days later.

← All decisions in July 2026

Sources