Endoscope, Flexible

Device Code: 1937

Product Code(s): GCQ

Device Classification Information

Device Type ID1937
Device NameEndoscope, Flexible
Regulation DescriptionEndoscope 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)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(k)
CFR Regulation Number876.1500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGCQ
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 ID1937
DeviceEndoscope, Flexible
Product CodeGCQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
Device Problems
Detachment Of Device Or Device Component
1
Contamination / Decontamination Problem
1
Total Device Problems 2
Recalls
Manufacturer Recall Class Date Posted
1
Integrated Medical Systems Inc
II Feb-25-2016
TPLC Last Update: 2019-04-02 20:02:16

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