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U.S. Department of Health and Human Services

Product Classification
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Device urethral insert with pump for bladder drainage
Regulation Description Urethral insert with pump for bladder drainage.
Definition The device is intended to empty urine from the bladder under patient control.
Physical State A catheter-like device with internal pump mechanism that is placed in the urethra.
Technical Method Under patient control, the internal pump inside the urethral insert draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired.
Target Area The device is placed in the urethra.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePIH
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.5140
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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