mJOULE RF System and Accessories
K-Number: K222958 · 2024-04-23
ApplicantSciton, Inc
Decision Date2024-04-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
mJOULE RF System and Accessories is a medical device manufactured by Sciton, Inc. It received FDA 510(k) clearance on 2024-04-23 under approval number K222958. 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 mJOULE RF System and Accessories?
mJOULE RF System and Accessories is a medical device that received FDA 510(k) clearance on 2024-04-23. It is manufactured by Sciton, Inc. The 510(k) number is K222958.
When was mJOULE RF System and Accessories approved by the FDA?
mJOULE RF System and Accessories received FDA 510(k) clearance on 2024-04-23, under approval number K222958.
What company makes mJOULE RF System and Accessories?
mJOULE RF System and Accessories is manufactured by Sciton, Inc.
What is the FDA product code for mJOULE RF System and Accessories?
The FDA product code for mJOULE RF System and Accessories is GEI.
Related Clinical Trials
Other Devices by Sciton, Inc
Related Devices (Code: GEI)
K161307NICO MyriadNico Corporation
K163190InMode RF SystemInmode MD , Ltd.
K163373PK AIMGyrus Acmi, Inc.
K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL
K162676Voyant Open Fusion DeviceApplied Medical Resources
K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien
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.