Accessories, Photographic, For Endoscope (exclude Light Sources)

Device Code: 1788

Product Code(s): FEM

Device Classification Information

Device Type ID1788
Device NameAccessories, Photographic, For Endoscope (exclude Light Sources)
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) Exempt
CFR Regulation Number876.1500 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFEM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1788
DeviceAccessories, Photographic, For Endoscope (exclude Light Sources)
Product CodeFEM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
Device Problems
Break
7
Device Operational Issue
6
Device Operates Differently Than Expected
4
Caster
4
Mechanical Problem
3
Lack Of Maintenance Documentation Or Guidelines
2
Thermal Decomposition Of Device
2
Loose Or Intermittent Connection
2
Power Cord
2
Sparking
2
Transformer
1
Misassembled
1
Melted
1
Smoking
1
Detachment Of Device Component
1
Unintended Collision
1
Unintended Movement
1
Component Incompatible
1
Loss Of Power
1
Wheel
1
Misassembly By Users
1
Device Damaged Prior To Use
1
Misassembly During Maintenance / Repair
1
Disconnection
1
Output Problem
1
Noise, Audible
1
Total Device Problems 50
TPLC Last Update: 2019-04-02 19:59:37

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