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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 / K251994

510(k) cleared

Arthrex Synergy Vision Imaging System

Arthrex, Inc. · Oct 16, 2025 · K251994

FDA cleared the Arthrex Synergy Vision Imaging System from Arthrex, Inc. on Oct 16, 2025 under K251994, 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 Jun 27, 2025. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262357 (Arthrex Bioabsorbable PushLock Suture Anchors), K260624 (Arthrex Radial Head Replacement System), K260018 (Arthrex FiberButton), K260809 (Arthrex Sterile VAL and VAL KreuLock Compression Screw System).

Questions & Answers

What did FDA clear under K251994?

K251994 is the FDA 510(k) for Arthrex Synergy Vision Imaging System, submitted by Arthrex, Inc.. FDA's decision date was Oct 16, 2025, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Arthrex Synergy Vision Imaging System?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K251994.

How long did the K251994 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Oct 16, 2025, 111 days later.

← All decisions in October 2025