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U.S. Department of Health and Human Services

Product Classification

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Device system, ablation, ultrasound and accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Intended for use as a surgical tool for coagulation and ablation of soft tissue.This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNTB
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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