Endoscopic Magnetic Retriever

Device Code: 1745

Product Code(s): FCC

Definition: To Endoscopically Retrieve Magnetic Foreign Objects

Device Classification Information

Device Type ID1745
Device NameEndoscopic Magnetic Retriever
Physical StateMagnetic Retriever
Technical MethodPlace Through Endoscope To Attract, Capture, And Remove Magnet Foreign Bodies
Target AreaMagnetic Foreign Bodies In Gi And Gu Tract
Regulation DescriptionEndoscope 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)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(k)
CFR Regulation Number876.1500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFCC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID1745
DeviceEndoscopic Magnetic Retriever
Product CodeFCC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
TPLC Last Update: 2019-04-02 19:58:55

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