Cleared Traditional

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

K250483 · Stryker Instruments · Cardiovascular

Sep 2025

Decision

202d

Days

Class 2

Risk

About This 510(k) Submission

K250483 is an FDA 510(k) clearance for the PhotonBlade 3; PhotonBlade 3 Smoke Evacuation, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on September 9, 2025, 202 days after receiving the submission on February 19, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K250483 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2025
Decision Date	September 09, 2025
Days to Decision	202 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).