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U.S. Department of Health and Human Services

Product Classification

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Device pediatric esophageal atresia anastomosis device
Regulation Description Gastrointestinal tube and accessories.
Definition Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter.
Physical State Plastic tubes, neodymium iron boron magnets
Technical Method Uses magnets advanced through esophageal and gastric catheters to bore through tissue and create an anastomosis.
Target Area Atretic esophageal ends
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePTK
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type HDE - Humanitarian Device Exemption
Regulation Number 876.5980
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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