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510(k) K213135

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge by Chirurgie Innovation — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2022
Date Received
September 27, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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