| Device Type ID | 86 |
| Device Name | Laryngoscope, Non-rigid |
| Regulation Description | Flexible Laryngoscope. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.5530 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CAL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 86 |
| Device | Laryngoscope, Non-rigid |
| Product Code | CAL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Flexible Laryngoscope. |
| CFR Regulation Number | 868.5530 [🔎] |
| Device Problems | |
|---|---|
Battery Problem | 9 |
Activation, Positioning Or Separation Problem | 5 |
Device Reprocessing Problem | 4 |
Failure To Conduct | 4 |
Metal Shedding Debris | 3 |
Difficult To Remove | 2 |
Difficult To Insert | 2 |
Microbial Contamination Of Device | 2 |
Display Or Visual Feedback Problem | 1 |
Flaked | 1 |
Detachment Of Device Component | 1 |
Poor Quality Image | 1 |
Material Deformation | 1 |
Positioning Failure | 1 |
Material Fragmentation | 1 |
Delamination | 1 |
Inadequate Lighting | 1 |
| Total Device Problems | 40 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Pentax Medical Company | II | Jun-28-2016 |