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510(k) K250522

Multi4 System by Multi4 Medical AB — Product Code FAS

K250522 is an FDA 510(k) premarket notification submitted by Multi4 Medical AB for the device "Multi4 System". The FDA issued a decision of Substantially Equivalent on June 27, 2025. 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
June 27, 2025
Date Received
February 21, 2025
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