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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic morcellator gastroenterology
Regulation Description Hysteroscope and accessories.
Definition For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)
Physical State Rotating, cutting cannula with aspiration of tissue
Technical Method Mechanical removal of gastrointestinal tissue
Target Area Gastrointestinal tract
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Gastroenterology/Urology
Product CodePTE
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 884.1690
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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