Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Multi4 System

K-Number: K250522 · 2025-06-27

ApplicantMulti4 Medical AB
Decision Date2025-06-27
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Multi4 System is a medical device manufactured by Multi4 Medical AB. It received FDA 510(k) clearance on 2025-06-27 under approval number K250522. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multi4 System?

Multi4 System is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Multi4 Medical AB. The 510(k) number is K250522.

When was Multi4 System approved by the FDA?

Multi4 System received FDA 510(k) clearance on 2025-06-27, under approval number K250522.

What company makes Multi4 System?

Multi4 System is manufactured by Multi4 Medical AB.

What is the FDA product code for Multi4 System?

The FDA product code for Multi4 System is FAS.

Related Devices (Code: FAS)

K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOmnitech Systems, Inc. K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH K163090Plasma Edge SystemChirurgie Innovation K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH K210394Electrosurgical accessoryDornier Medtech America, Inc. K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑