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510(k) K242266

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation by Stryker Instruments — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2024
Date Received
August 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

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  • K240526 — POWEReam Xia/Serrato (April 29, 2024)

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