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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 / K253679

510(k) cleared

Hydro Irrigation System

Stryker Instruments · May 8, 2026 · K253679

FDA cleared the Hydro Irrigation System from Stryker Instruments on May 8, 2026 under K253679, 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 21, 2025. The decision came 168 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Instruments has 4 other decisions in the tracker over the last 12 months: K261544 (Hydro Irrigation System), K252282 (SurgiCount+ System), K251971 (RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer), K250483 (PhotonBlade 3; PhotonBlade 3 Smoke Evacuation).

Questions & Answers

What did FDA clear under K253679?

K253679 is the FDA 510(k) for Hydro Irrigation System, submitted by Stryker Instruments. FDA's decision date was May 8, 2026, under product code GWG (Endoscope, Neurological).

Who makes the Hydro Irrigation System?

Stryker Instruments, based in Portage, MI, is the applicant of record for K253679.

How long did the K253679 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on May 8, 2026, 168 days later.

← All decisions in May 2026