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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 / November 2025 / K242606

510(k) cleared

Nuvis® Wireless HD Camera System (Nuvis-2K)

Integrated Endoscopy, Inc. · Nov 20, 2025 · K242606

FDA cleared the Nuvis® Wireless HD Camera System (Nuvis-2K) from Integrated Endoscopy, Inc. on Nov 20, 2025 under K242606, 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 Aug 30, 2024. The decision came 447 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 Integrated Endoscopy, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242606?

K242606 is the FDA 510(k) for Nuvis® Wireless HD Camera System (Nuvis-2K), submitted by Integrated Endoscopy, Inc.. FDA's decision date was Nov 20, 2025, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Nuvis® Wireless HD Camera System (Nuvis-2K)?

Integrated Endoscopy, Inc., based in Irvine, CA, is the applicant of record for K242606.

How long did the K242606 review take?

FDA received the submission on Aug 30, 2024 and issued its decision on Nov 20, 2025, 447 days later.

← All decisions in November 2025