NuEra Tight RF Family
K-Number: K223856 · 2023-08-11
ApplicantBios S.R.L.
Decision Date2023-08-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NuEra Tight RF Family is a medical device manufactured by Bios S.R.L.. It received FDA 510(k) clearance on 2023-08-11 under approval number K223856. 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 NuEra Tight RF Family?
NuEra Tight RF Family is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Bios S.R.L.. The 510(k) number is K223856.
When was NuEra Tight RF Family approved by the FDA?
NuEra Tight RF Family received FDA 510(k) clearance on 2023-08-11, under approval number K223856.
What company makes NuEra Tight RF Family?
NuEra Tight RF Family is manufactured by Bios S.R.L..
What is the FDA product code for NuEra Tight RF Family?
The FDA product code for NuEra Tight RF Family is GEI.
Other Devices by Bios S.R.L.
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.