Device, Locking, For Intestinal Clamp

Device Code: 1811

Product Code(s): FFR

Device Classification Information

Device Type ID1811
Device NameDevice, Locking, For Intestinal Clamp
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 CodeFFR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1811
DeviceDevice, Locking, For Intestinal Clamp
Product CodeFFR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Gastroenterology-urology Surgical Instrument And Accessories.
CFR Regulation Number876.4730 [🔎]
TPLC Last Update: 2019-04-02 19:59:59

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