FDA.report

510(k) K250522

Device
Multi4 System
Applicant
Multi4 Medical AB
510(k) number
K250522
Product code
FAS
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-27
Date received
2025-02-21
Regulation
876.4300
Classification name
Electrode, Electrosurgical, Active, Urological
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Miden Melle-Hannah
Address
Bäckalyckevägen 15 Jönköping SE 553 13 553 13

FDA Registration Numbers

Source Documents

510(k) summary PDF

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