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U.S. Department of Health and Human Services

Product Classification
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Device pancreatic stent, covered, metallic, removable
Definition To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Physical State stent and delivery system, endoscope
Technical Method Facilitates and secures the apposition of tissue for transmural placement of stent
Target Area pancreatic pseudocysts adherent to bowel wall
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePCU
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5015
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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