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U.S. Department of Health and Human Services

Product Classification

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Device gastrostomy tube holder
Regulation Description Gastrointestinal tube and accessories.
Definition Intended to support, secure, and hold gastrostomy tubes.
Physical State Cloth material held together by fasteners
Technical Method Holds gastrostomy tube in place using strap
Target Area Abdomen
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePLI
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 876.5980
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible