| Device Type ID | 5456 |
| Device Name | Laryngoscope, Endoscope |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | General & Plastic Surgery |
| 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) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GCI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5456 |
| Device | Laryngoscope, Endoscope |
| Product Code | GCI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Torn Material | 129 |
Break | 78 |
Detachment Of Device Component | 60 |
Detachment Of Device Or Device Component | 42 |
Optical Problem | 40 |
Material Split, Cut Or Torn | 36 |
Material Separation | 34 |
Material Rupture | 12 |
Failure To Conduct | 11 |
Bags | 7 |
Difficult To Remove | 6 |
Charging Problem | 5 |
Difficult To Open Or Close | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Bent | 3 |
Material Fragmentation | 3 |
Hole In Material | 3 |
Separation Failure | 2 |
Fitting Problem | 2 |
Difficult To Insert | 2 |
Device Markings / Labelling Problem | 2 |
Positioning Problem | 2 |
Mechanical Problem | 2 |
Material Perforation | 2 |
Burst Container Or Vessel | 2 |
Difficult Or Delayed Positioning | 2 |
Connection Problem | 2 |
Component Missing | 2 |
Appropriate Term/Code Not Available | 1 |
Failure To Charge | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Device Difficult To Maintain | 1 |
Power Problem | 1 |
Product Quality Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Or Device Fragments Location Unknown | 1 |
Crack | 1 |
Insufficient Information | 1 |
Mechanics Altered | 1 |
Loose Or Intermittent Connection | 1 |
Device Damaged Prior To Use | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Deformation | 1 |
Device Packaging Compromised | 1 |
Environmental Particulates | 1 |
Ring | 1 |
Out-Of-Box Failure | 1 |
| Total Device Problems | 520 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |