Probe, Rectal, Non-powered

Device Code: 1688

Product Code(s): EXX

Device Classification Information

Device Type ID1688
Device NameProbe, Rectal, Non-powered
Regulation DescriptionManual Gastroenterology-urology Surgical Instrument 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)
Gastroenterology Devices Branch (GEDB)
Submission Type510(K) Exempt
CFR Regulation Number876.4730 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEXX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1688
DeviceProbe, Rectal, Non-powered
Product CodeEXX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Gastroenterology-urology Surgical Instrument And Accessories.
CFR Regulation Number876.4730 [🔎]
TPLC Last Update: 2019-04-02 19:57:49

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