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U.S. Department of Health and Human Services

Product Classification

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Device pancreatic stent, covered, metallic, removable
Regulation Description Pancreatic drainage stent and delivery system.
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 Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type 510(k)
Regulation Number 876.5015
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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