Device |
electrosurgical vessel and/or tissue sealer. with built-in generator. |
Regulation Description |
Electrosurgical cutting and coagulation device and accessories. |
Definition |
Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed. |
Physical State |
Applicator/Dissector, RF Generator and Battery are integrated in a single handpiece. |
Technical Method |
Application of RF energy to heat and seal vessel/tissue followed by dissection of target vessel/tissue. |
Target Area |
Has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | PDG |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
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
|
Guidance Document
|
Third Party Review
|
Accredited Persons
|