Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
K-Number: K240614 · 2024-07-10
ApplicantOticon Medical AB
Decision Date2024-07-10
Product CodePFO
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS is a medical device manufactured by Oticon Medical AB. It received FDA 510(k) clearance on 2024-07-10 under approval number K240614. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS?
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS is a medical device that received FDA 510(k) clearance on 2024-07-10. It is manufactured by Oticon Medical AB. The 510(k) number is K240614.
When was Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS approved by the FDA?
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS received FDA 510(k) clearance on 2024-07-10, under approval number K240614.
What company makes Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS?
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS is manufactured by Oticon Medical AB.
What is the FDA product code for Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS?
The FDA product code for Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS is PFO.
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Related PubMed Literature
PMID: 42181028
Systematic biocompatibility assessment of 4-µm surface silicone implants.
Biomaterials and biosystems (2026)
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Advancing Public Health Through Internationally Coordinated Medical Device Registries Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".
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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.