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510(k) K061541

KSEA BIPOLAR ELECTROTOME by Ksea — Product Code FAS

K061541 is an FDA 510(k) premarket notification submitted by Ksea for the device "KSEA BIPOLAR ELECTROTOME". The FDA issued a decision of Substantially Equivalent on August 21, 2006. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2006
Date Received
June 5, 2006
Clearance Type
Traditional
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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FDA data resources