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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 / June 2026 / K253602

510(k) cleared

Precision S 4K Sinuscope

Stryker Endoscopy · Jun 4, 2026 · K253602

FDA cleared the Precision S 4K Sinuscope from Stryker Endoscopy on Jun 4, 2026 under K253602, a traditional 510(k). The device falls under product code GWG, Endoscope, Neurological, regulated at 21 CFR 882.1480 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 18, 2025. The decision came 198 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), DEN250040 (SportSuite Vision Software), 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 K253602?

K253602 is the FDA 510(k) for Precision S 4K Sinuscope, submitted by Stryker Endoscopy. FDA's decision date was Jun 4, 2026, under product code GWG (Endoscope, Neurological).

Who makes the Precision S 4K Sinuscope?

Stryker Endoscopy, based in San Jose, CA, is the applicant of record for K253602.

How long did the K253602 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Jun 4, 2026, 198 days later.

← All decisions in June 2026