Gastrostomy Tube Holder

Device Code: 2105

Product Code(s): PLI

Definition: Intended To Support, Secure, And Hold Gastrostomy Tubes

Device Classification Information

Device Type ID2105
Device NameGastrostomy Tube Holder
Physical StateCloth Material Held Together By Fasteners
Technical MethodHolds Gastrostomy Tube In Place Using Strap
Target AreaAbdomen
Regulation DescriptionGastrointestinal Tube And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type510(K) Exempt
CFR Regulation Number876.5980 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePLI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2105
DeviceGastrostomy Tube Holder
Product CodePLI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGastrointestinal Tube And Accessories.
CFR Regulation Number876.5980 [🔎]
TPLC Last Update: 2019-04-02 20:06:08

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