XERF
K-Number: K251327 · 2025-08-11
ApplicantLutronic Corporation
Decision Date2025-08-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
XERF is a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2025-08-11 under approval number K251327. 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 XERF?
XERF is a medical device that received FDA 510(k) clearance on 2025-08-11. It is manufactured by Lutronic Corporation. The 510(k) number is K251327.
When was XERF approved by the FDA?
XERF received FDA 510(k) clearance on 2025-08-11, under approval number K251327.
What company makes XERF?
XERF is manufactured by Lutronic Corporation.
What is the FDA product code for XERF?
The FDA product code for XERF is GEI.
Other Devices by Lutronic Corporation
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.