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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic electrosurgical clip cutting system
Regulation Description Endoscopic electrosurgical clip cutting system.
Definition To fragment metallic clips and remove them from the digestive tract.
Physical State Generator supplies energy to clip cutter, whose tip is placed on the opposite edges of the metallic clip, and direct current is applied to fragment the clip.
Technical Method Applies direct current across clip edges.
Target Area Gastrointestinal tract, digestive tract.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Gastroenterology/Urology
Product CodeQAG
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.4310
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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