Wristlet, Patient Return

Device Code: 1772

Product Code(s): FDL

Device Classification Information

Device Type ID1772
Device NameWristlet, Patient Return
Regulation DescriptionEndoscopic Electrosurgical Unit 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 Number876.4300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFDL
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 ID1772
DeviceWristlet, Patient Return
Product CodeFDL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscopic Electrosurgical Unit And Accessories.
CFR Regulation Number876.4300 [🔎]
TPLC Last Update: 2019-04-02 19:59:23

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