Plate, Patient

Device Code: 1765

Product Code(s): FDB

Device Classification Information

Device Type ID1765
Device NamePlate, Patient
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 CodeFDB
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 ID1765
DevicePlate, Patient
Product CodeFDB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscopic Electrosurgical Unit And Accessories.
CFR Regulation Number876.4300 [🔎]
TPLC Last Update: 2019-04-02 19:59:15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.