FDA 510(k)

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

N.º K: K250483 · 2025-09-09

Fecha de decisión2025-09-09

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K250483. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Stryker Instruments. The 510(k) number is K250483.

When did PhotonBlade 3; PhotonBlade 3 Smoke Evacuation receive FDA 510(k) clearance?

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation received FDA 510(k) clearance on 2025-09-09, under 510(k) number K250483.

Who is the listed applicant for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?

The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?

The FDA product code for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is GEI.

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Otros registros que enlistan a Stryker Instruments como solicitante

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)K261544Hydro Irrigation System K253679Hydro Irrigation System K252282SurgiCount+ System K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

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Fuente oficial

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