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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 / October 2025 / K253010

510(k) cleared

Mini Superhawk Suture Anchor System

Responsive Arthroscopy, LLC · Oct 14, 2025 · K253010

FDA cleared the Mini Superhawk Suture Anchor System from Responsive Arthroscopy, LLC on Oct 14, 2025 under K253010, 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 Sep 19, 2025. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

Responsive Arthroscopy, LLC has one other decision in the tracker over the last 12 months: K261632 (Thunderbolt System).

Questions & Answers

What did FDA clear under K253010?

K253010 is the FDA 510(k) for Mini Superhawk Suture Anchor System, submitted by Responsive Arthroscopy, LLC. FDA's decision date was Oct 14, 2025, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Mini Superhawk Suture Anchor System?

Responsive Arthroscopy, LLC, based in Minneapolis, MN, is the applicant of record for K253010.

How long did the K253010 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Oct 14, 2025, 25 days later.

← All decisions in October 2025

Sources