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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic tissue approximation device
Regulation Description Endoscope and accessories.
Definition To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Physical State may include: delivery instrument, applier, holder, connector, threading tool, needle-loading tool, ring implant, pin implant, knot pusher, sutures, staples, clips, tackers, fasteners
Technical Method Many methods to perform intended use. Insert instrument through endoscope at desired area of delivery.
Target Area Various tissues located within body cavities, hollow organs, and canals in GI and GU tract.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeOCW
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1500
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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