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U.S. Department of Health and Human Services

Product Classification
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Device submucosal injection agent
Regulation Description Endoscope and accessories.
Definition Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
Physical State Gel
Technical Method submucosal injection via endoscopy
Target Area Gi tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePLL
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 876.1500
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
Third Party Review Not Third Party Eligible
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