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510(k) K232633

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter by Boston Scientific — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2023
Date Received
August 30, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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