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510(k) Data Aggregation
K Number
K251566Device Name
TS-RF Generator (STS10)Manufacturer
Date Cleared
2025-11-17
(179 days)
Product Code
Regulation Number
878.4400Type
TraditionalReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.
Device Description
The TS-RF Generator consists of an RF generator, cables, and components. This TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue. Radiofrequency power is supplied and controlled with a maximum of 50 watts. Data Logs can be stored by connecting the USB Flash Driver with the communication terminal of the rear panel of the RF generator.
AI/ML Overview
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