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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 / January 2026 / K253611

510(k) cleared

Falco Fusion System

Mcnicoll Surgical, Inc. · Jan 29, 2026 · K253611

FDA cleared the Falco Fusion System from Mcnicoll Surgical, Inc. on Jan 29, 2026 under K253611, a traditional 510(k). The device falls under product code OUR, Sacroiliac Joint Fixation, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 18, 2025. The decision came 72 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Mcnicoll Surgical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253611?

K253611 is the FDA 510(k) for Falco Fusion System, submitted by Mcnicoll Surgical, Inc.. FDA's decision date was Jan 29, 2026, under product code OUR (Sacroiliac Joint Fixation).

Who makes the Falco Fusion System?

Mcnicoll Surgical, Inc., based in Quebec City, is the applicant of record for K253611.

How long did the K253611 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Jan 29, 2026, 72 days later.

← All decisions in January 2026