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U.S. Department of Health and Human Services

Product Classification
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Device forceps, biopsy, electric surgical hemostasis within tracheobronchial tree
Regulation Description Endoscopic electrosurgical unit and accessories.
Definition An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree
Physical State Electrosurgical forceps and may include accessories.
Technical Method The device is deployed through a bronchoscope.
Target Area Tracheobronchial tree.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Anesthesiology
Product CodeQEC
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 876.4300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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