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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 / April 2026 / K242163

510(k) cleared

SmartSurgN Visualization System

SmartsurgN, Inc. · Apr 20, 2026 · K242163

FDA cleared the SmartSurgN Visualization System from SmartsurgN, Inc. on Apr 20, 2026 under K242163, a traditional 510(k). The device falls under product code OWN, Confocal Optical Imaging, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 24, 2024. The decision came 635 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 SmartsurgN, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242163?

K242163 is the FDA 510(k) for SmartSurgN Visualization System, submitted by SmartsurgN, Inc.. FDA's decision date was Apr 20, 2026, under product code OWN (Confocal Optical Imaging).

Who makes the SmartSurgN Visualization System?

SmartsurgN, Inc., based in San Jose, CA, is the applicant of record for K242163.

How long did the K242163 review take?

FDA received the submission on Jul 24, 2024 and issued its decision on Apr 20, 2026, 635 days later.

← All decisions in April 2026