Product Classification

• 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

• Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• smo india
• third party review group, llc