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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 / October 2025 / K250551

510(k) cleared

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

Shenzhen Sophway Technology Co., Ltd. · Oct 2, 2025 · K250551

FDA cleared the 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) from Shenzhen Sophway Technology Co., Ltd. on Oct 2, 2025 under K250551, 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 25, 2025. The decision came 219 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 Shenzhen Sophway Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250551?

K250551 is the FDA 510(k) for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N), submitted by Shenzhen Sophway Technology Co., Ltd.. FDA's decision date was Oct 2, 2025, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

Shenzhen Sophway Technology Co., Ltd., based in Shenzhen, is the applicant of record for K250551.

How long did the K250551 review take?

FDA received the submission on Feb 25, 2025 and issued its decision on Oct 2, 2025, 219 days later.

← All decisions in October 2025