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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 / May 2026 / K261037

510(k) cleared

780 nm SPY Portable Handheld Imaging (SPY-PHI) System

Stryker Endoscopy · May 28, 2026 · K261037

FDA cleared the 780 nm SPY Portable Handheld Imaging (SPY-PHI) System from Stryker Endoscopy on May 28, 2026 under K261037, a traditional 510(k). The device falls under product code IZI, System, X-Ray, Angiographic, regulated at 21 CFR 892.1600 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 30, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

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), DEN250040 (SportSuite Vision Software), K253602 (Precision S 4K Sinuscope), K260185 (1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality).

Questions & Answers

What did FDA clear under K261037?

K261037 is the FDA 510(k) for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System, submitted by Stryker Endoscopy. FDA's decision date was May 28, 2026, under product code IZI (System, X-Ray, Angiographic).

Who makes the 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?

Stryker Endoscopy, based in San Jose, CA, is the applicant of record for K261037.

How long did the K261037 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on May 28, 2026, 59 days later.

← All decisions in May 2026