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U.S. Department of Health and Human Services

Product Classification
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Device anal fistula closure device
Definition An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device.
Physical State The device is an absorbable, barbed, helical screw.
Technical Method Seals the internal fistula opening by drawing the internal surfaces of the fistula tract together to encourage healing by primary intention.
Target Area Anus and rectum
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQML
Premarket Review Plastic and Reconstructive Surgery Devices (DHT4B)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4835
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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