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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 / March 2026 / K253267

510(k) cleared

CORIS System

Nanosonics Limited · Mar 5, 2026 · K253267

FDA cleared the CORIS System from Nanosonics Limited on Mar 5, 2026 under K253267, a traditional 510(k). The device falls under product code SEW, Automated Endoscope Channel Cleaner, regulated at 21 CFR 880.6994 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 29, 2025. The decision came 157 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 Nanosonics Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253267?

K253267 is the FDA 510(k) for CORIS System, submitted by Nanosonics Limited. FDA's decision date was Mar 5, 2026, under product code SEW (Automated Endoscope Channel Cleaner).

Who makes the CORIS System?

Nanosonics Limited, based in Macquarie Park, is the applicant of record for K253267.

How long did the K253267 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Mar 5, 2026, 157 days later.

← All decisions in March 2026