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FDA 510(k)

InbellaIgnite RF System

K-Number: K251435 · 2026-01-27

ApplicantInbella Medical, Inc.
Decision Date2026-01-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InbellaIgnite RF 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 2026-01-27 under 510(k) number K251435. 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 InbellaIgnite RF System?

InbellaIgnite RF System is a medical device that received FDA 510(k) clearance on 2026-01-27. The listed applicant is Inbella Medical, Inc.. The 510(k) number is K251435.

When did InbellaIgnite RF System receive FDA 510(k) clearance?

InbellaIgnite RF System received FDA 510(k) clearance on 2026-01-27, under 510(k) number K251435.

Who is the listed applicant for InbellaIgnite RF 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 InbellaIgnite RF System?

The FDA product code for InbellaIgnite RF System is GEI.

Other records listing Inbella Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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