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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K250483
Device Name PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
Applicant
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Applicant Contact Miriam Giltinan
Correspondent
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Correspondent Contact Miriam Giltinan
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
SFQ  
Date Received02/19/2025
Decision Date 09/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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