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THE TAPE

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 / K262369

510(k) cleared

AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down

Stryker Endoscopy · Jul 30, 2026 · K262369

FDA cleared the AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down from Stryker Endoscopy on Jul 30, 2026 under K262369, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 10, 2026. The decision came 20 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: DEN250040 (SportSuite Vision Software), 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 K262369?

K262369 is the FDA 510(k) for AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down, submitted by Stryker Endoscopy. FDA's decision date was Jul 30, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down?

Stryker Endoscopy, based in San Jose, CA, is the applicant of record for K262369.

How long did the K262369 review take?

FDA received the submission on Jul 10, 2026 and issued its decision on Jul 30, 2026, 20 days later.

← All decisions in July 2026