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U.S. Department of Health and Human Services

Product Classification
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Device dynamic rectal control system
Regulation Description Rectal control system.
Definition Intended to treat fecal incontinence by controlling the size of the rectal lumen.
Physical State The device includes a balloon like device placed in the vagina and an external regulator and inflation pump to control the state of expansion.
Technical Method The device is inserted in the vagina and includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts to allow normal passage of stool.
Target Area Vaginal placement for compression of rectum
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePJH
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 876.5930
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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