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FDA 510(k)

InbellaBody System

K-Number: K250200 · 2025-02-11

ApplicantInbella Medical, Inc.
Decision Date2025-02-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InbellaBody 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 2025-02-11 under 510(k) number K250200. 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 InbellaBody System?

InbellaBody System is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Inbella Medical, Inc.. The 510(k) number is K250200.

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

InbellaBody System received FDA 510(k) clearance on 2025-02-11, under 510(k) number K250200.

Who is the listed applicant for InbellaBody 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 InbellaBody System?

The FDA product code for InbellaBody 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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