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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 / June 2026 / K261544

510(k) cleared

Hydro Irrigation System

Stryker Instruments · Jun 17, 2026 · K261544

FDA cleared the Hydro Irrigation System from Stryker Instruments on Jun 17, 2026 under K261544, a traditional 510(k). The device falls under product code EOB, Nasopharyngoscope (Flexible Or Rigid), regulated at 21 CFR 874.4760 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on May 8, 2026. The decision came 40 days later, inside the 90 FDA-day goal for a 510(k).

Stryker Instruments has 4 other decisions in the tracker over the last 12 months: K253679 (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 K261544?

K261544 is the FDA 510(k) for Hydro Irrigation System, submitted by Stryker Instruments. FDA's decision date was Jun 17, 2026, under product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

Who makes the Hydro Irrigation System?

Stryker Instruments, based in Portage, MI, is the applicant of record for K261544.

How long did the K261544 review take?

FDA received the submission on May 8, 2026 and issued its decision on Jun 17, 2026, 40 days later.

← All decisions in June 2026