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 a medical device manufactured by Inbella Medical, Inc.. It received FDA 510(k) clearance on 2026-01-27 under approval 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. It is manufactured by Inbella Medical, Inc.. The 510(k) number is K251435.
When was InbellaIgnite RF System approved by the FDA?
InbellaIgnite RF System received FDA 510(k) clearance on 2026-01-27, under approval number K251435.
What company makes InbellaIgnite RF System?
InbellaIgnite RF System is manufactured by Inbella Medical, Inc..
What is the FDA product code for InbellaIgnite RF System?
The FDA product code for InbellaIgnite RF System is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.