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U.S. Department of Health and Human Services

Product Classification

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Device transurethral occlusion insert, urinary incontinence-control, female
Definition Transurethral insert for urinary occlusion/control in women with urinary incontinence
Physical State balloon tipped catheter, insertion device
Technical Method A balloon tipped catheter is inserted into the urethra. Deflation or removal of the device results in fluid movement
Target Area urethra
Review Panel Gastroenterology/Urology
Product CodeOCK
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible