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U.S. Department of Health and Human Services

Product Classification

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Device surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue.
Physical State The device tip delivers energy to provide cutting, coagulation, and/or ablation of the contacted tissue
Technical Method The device energy source used to provide cutting, coagulation and/or ablation may be radio frequency (RF), cryogenic, laser or ultrasound
Target Area Cardiac tissue.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Cardiovascular
Product CodeOCL
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Electrophysiology Devices Branch (CEDB)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons

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