Punch, Biopsy

Device Code: 1750

Product Code(s): FCI

Device Classification Information

Device Type ID1750
Device NamePunch, Biopsy
Regulation DescriptionGastroenterology-urology Biopsy Instrument.
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 Number876.1075 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFCI
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 ID1750
DevicePunch, Biopsy
Product CodeFCI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGastroenterology-urology Biopsy Instrument.
CFR Regulation Number876.1075 [🔎]
TPLC Last Update: 2019-04-02 19:59:00

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