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U.S. Department of Health and Human Services

Product Classification

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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 CodePDG
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
Third Party Review Not Third Party Eligible
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