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FDA 510(k)

InbellaMulti System

K-Number: K252367 · 2025-10-15

ApplicantInbella Medical, Inc.
Decision Date2025-10-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InbellaMulti System is a medical device manufactured by Inbella Medical, Inc.. It received FDA 510(k) clearance on 2025-10-15 under approval number K252367. 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 InbellaMulti System?

InbellaMulti System is a medical device that received FDA 510(k) clearance on 2025-10-15. It is manufactured by Inbella Medical, Inc.. The 510(k) number is K252367.

When was InbellaMulti System approved by the FDA?

InbellaMulti System received FDA 510(k) clearance on 2025-10-15, under approval number K252367.

What company makes InbellaMulti System?

InbellaMulti System is manufactured by Inbella Medical, Inc..

What is the FDA product code for InbellaMulti System?

The FDA product code for InbellaMulti System is GEI.

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Official Source

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