Jelly, Lubricating, For Transurethral Surgical Instrument

Device Code: 1848

Product Code(s): FHX

Device Classification Information

Device Type ID1848
Device NameJelly, Lubricating, For Transurethral Surgical Instrument
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 CodeFHX
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 ID1848
DeviceJelly, Lubricating, For Transurethral Surgical Instrument
Product CodeFHX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
TPLC Last Update: 2019-04-02 20:00:40

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