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U.S. Department of Health and Human Services

Product Classification

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Device rectal insert
Regulation Description Gastrointestinal tube and accessories.
Definition Acts as a barrier to the passage of fecal matter through the rectum.
Physical State Comprised of a silicone Insert and a plastic fingertip applicator. The Insert has a barbell shape, the end which sits inside of the rectum ranges in size from 22 mm to 28 mm in width. The Insert is 35 mm long and the external flare is 24 mm.
Technical Method Designed for self-insertion to seal and prevent the involuntary leakage of stool from the rectum.
Target Area To be placed across the anal sphincter.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePBP
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type 510(k)
Regulation Number 876.5980
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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