Cystometric Gas (carbon-dioxide) On Hydraulic Device

Device Code: 1727

Product Code(s): FAP

Device Classification Information

Device Type ID1727
Device NameCystometric Gas (carbon-dioxide) On Hydraulic Device
Regulation DescriptionUrodynamics Measurement System.
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) Exempt
CFR Regulation Number876.1620 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFAP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1727
DeviceCystometric Gas (carbon-dioxide) On Hydraulic Device
Product CodeFAP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionUrodynamics Measurement System.
CFR Regulation Number876.1620 [🔎]
Device Problems
Device Contaminated During Manufacture Or Shipping
1
Material Rupture
1
Total Device Problems 2
Recalls
Manufacturer Recall Class Date Posted
1
Teleflex Medical Europe Ltd
II Apr-12-2018
TPLC Last Update: 2019-04-02 19:58:39

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