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510(k) Data Aggregation
K Number
K221743Device Name
Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes
Manufacturer
Date Cleared
2023-09-07
(449 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Bonss Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Radio Frequency Plasma Surgical Systems are indicated for cutting, resection, ablation and coagulation of soft tissues and hemostasis of blood vessels in otorhinolaryngology head and neck surgery procedures. Radio Frequency Plasma Surgical Electrodes are used in combination with the compatible RF or Plasma device for cutting, resection, vaporization, ablation and coagulation of soft tissues and hemostasis of blood vessels in otorhinolaryngology head and neck surgery procedures.
Device Description
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