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 Code | OCL |
Premarket Review |
Office of 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 |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Guidance Document
|
Third Party Review
|
Accredited Persons
|