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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 / June 2026 / K260414

510(k) cleared

Tech-Image Video Endoscope System

Tech-Image CO., LTD. · Jun 10, 2026 · K260414

FDA cleared the Tech-Image Video Endoscope System from Tech-Image CO., LTD. on Jun 10, 2026 under K260414, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 9, 2026. The decision came 121 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 Tech-Image CO., LTD. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260414?

K260414 is the FDA 510(k) for Tech-Image Video Endoscope System, submitted by Tech-Image CO., LTD.. FDA's decision date was Jun 10, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Tech-Image Video Endoscope System?

Tech-Image CO., LTD., based in Taipei City, is the applicant of record for K260414.

How long did the K260414 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Jun 10, 2026, 121 days later.

← All decisions in June 2026