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)

InbellaMAX System

K-Number: K252215 · 2025-07-25

ApplicantInbella Medical , Ltd.
Decision Date2025-07-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InbellaMAX System is a medical device manufactured by Inbella Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-25 under approval number K252215. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InbellaMAX System?

InbellaMAX System is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by Inbella Medical , Ltd.. The 510(k) number is K252215.

When was InbellaMAX System approved by the FDA?

InbellaMAX System received FDA 510(k) clearance on 2025-07-25, under approval number K252215.

What company makes InbellaMAX System?

InbellaMAX System is manufactured by Inbella Medical , Ltd..

What is the FDA product code for InbellaMAX System?

The FDA product code for InbellaMAX System is GEI.

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑