Device Type ID | 1788 |
Device Name | Accessories, Photographic, For Endoscope (exclude Light Sources) |
Regulation Description | Endoscope And Accessories. |
Regulation Medical Specialty | Gastroenterology/Urology |
Review Panel | Gastroenterology/Urology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 876.1500 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FEM |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1788 |
Device | Accessories, Photographic, For Endoscope (exclude Light Sources) |
Product Code | FEM |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Endoscope And Accessories. |
CFR Regulation Number | 876.1500 [🔎] |
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 |