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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 / February 2026 / K260108

510(k) cleared

L12 LED Light Source with AIM

Stryker Endoscopy · Feb 12, 2026 · K260108

FDA cleared the L12 LED Light Source with AIM from Stryker Endoscopy on Feb 12, 2026 under K260108, a special 510(k). The device falls under product code OWN, Confocal Optical Imaging, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 14, 2026. The decision came 29 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), K261037 (780 nm SPY Portable Handheld Imaging (SPY-PHI) System).

Questions & Answers

What did FDA clear under K260108?

K260108 is the FDA 510(k) for L12 LED Light Source with AIM, submitted by Stryker Endoscopy. FDA's decision date was Feb 12, 2026, under product code OWN (Confocal Optical Imaging).

Who makes the L12 LED Light Source with AIM?

Stryker Endoscopy, based in San Jose, CA, is the applicant of record for K260108.

How long did the K260108 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Feb 12, 2026, 29 days later.

← All decisions in February 2026