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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 / July 2026 / DEN250040

510(k) cleared

SportSuite Vision Software

Stryker Endoscopy · Jul 17, 2026 · DEN250040

FDA cleared the SportSuite Vision Software from Stryker Endoscopy on Jul 17, 2026 under DEN250040, a direct 510(k). The device falls under product code SIT, Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System, regulated at 21 CFR 888.1150 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 2, 2025. The decision came 318 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Endoscopy has 7 other decisions in the tracker over the last 12 months: K262369 (AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down), K253602 (Precision S 4K Sinuscope), K261037 (780 nm SPY Portable Handheld Imaging (SPY-PHI) System), K260185 (1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality).

Questions & Answers

What did FDA clear under DEN250040?

DEN250040 is the FDA 510(k) for SportSuite Vision Software, submitted by Stryker Endoscopy. FDA's decision date was Jul 17, 2026, under product code SIT (Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System).

Who makes the SportSuite Vision Software?

Stryker Endoscopy, based in San Jose, CA, is the applicant of record for DEN250040.

How long did the DEN250040 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Jul 17, 2026, 318 days later.

← All decisions in July 2026