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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 the device name listed in this FDA 510(k) record. The listed applicant is Inbella Medical, Inc.. It received FDA 510(k) clearance on 2025-10-15 under 510(k) 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. The listed applicant is Inbella Medical, Inc.. The 510(k) number is K252367.

When did InbellaMulti System receive FDA 510(k) clearance?

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

Who is the listed applicant for InbellaMulti System?

The FDA 510(k) record lists Inbella Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InbellaMulti System?

The FDA product code for InbellaMulti System is GEI.

Other records listing Inbella Medical, Inc. as applicant

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Official Source

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

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