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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 Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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