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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 / K252020

510(k) cleared

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly

Hand Biomechanics Lab, Inc. · Oct 15, 2025 · K252020

FDA cleared the TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly from Hand Biomechanics Lab, Inc. on Oct 15, 2025 under K252020, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 30, 2025. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hand Biomechanics Lab, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252020?

K252020 is the FDA 510(k) for TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly, submitted by Hand Biomechanics Lab, Inc.. FDA's decision date was Oct 15, 2025, under product code HRX (Arthroscope).

Who makes the TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly?

Hand Biomechanics Lab, Inc., based in Sacramento, CA, is the applicant of record for K252020.

How long did the K252020 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Oct 15, 2025, 107 days later.

← All decisions in October 2025