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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 a medical device manufactured by Inbella Medical, Inc.. It received FDA 510(k) clearance on 2025-02-11 under approval 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. It is manufactured by Inbella Medical, Inc.. The 510(k) number is K250200.

When was InbellaBody System approved by the FDA?

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

What company makes InbellaBody System?

InbellaBody System is manufactured by Inbella Medical, Inc..

What is the FDA product code for InbellaBody System?

The FDA product code for InbellaBody System is GEI.

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Official Source

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