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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 / September 2025 / K250483

510(k) cleared

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

Stryker Instruments · Sep 9, 2025 · K250483

FDA cleared the PhotonBlade 3; PhotonBlade 3 Smoke Evacuation from Stryker Instruments on Sep 9, 2025 under K250483, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 19, 2025. The decision came 202 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), 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).

Questions & Answers

What did FDA clear under K250483?

K250483 is the FDA 510(k) for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation, submitted by Stryker Instruments. FDA's decision date was Sep 9, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?

Stryker Instruments, based in Portage, MI, is the applicant of record for K250483.

How long did the K250483 review take?

FDA received the submission on Feb 19, 2025 and issued its decision on Sep 9, 2025, 202 days later.

← All decisions in September 2025

Sources