Inbella RF System
K-Number: K243737 · 2025-01-03
ApplicantInbella Medical, Inc.
Decision Date2025-01-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Inbella RF System is a medical device manufactured by Inbella Medical, Inc.. It received FDA 510(k) clearance on 2025-01-03 under approval number K243737. 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 Inbella RF System?
Inbella RF System is a medical device that received FDA 510(k) clearance on 2025-01-03. It is manufactured by Inbella Medical, Inc.. The 510(k) number is K243737.
When was Inbella RF System approved by the FDA?
Inbella RF System received FDA 510(k) clearance on 2025-01-03, under approval number K243737.
What company makes Inbella RF System?
Inbella RF System is manufactured by Inbella Medical, Inc..
What is the FDA product code for Inbella RF System?
The FDA product code for Inbella 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.