Device, Thermal, Hemorrhoids

Device Code: 2193

Product Code(s): LKX

Device Classification Information

Device Type ID2193
Device NameDevice, Thermal, Hemorrhoids
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)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLKX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2193
DeviceDevice, Thermal, Hemorrhoids
Product CodeLKX
TPLC Last Update: 2019-04-02 20:07:29

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