| Device Type ID | 12 |
| Device Name | Stylet, Tracheal Tube |
| Regulation Description | Tracheal Tube Stylet. |
| 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 | 868.5790 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BSR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 12 |
| Device | Stylet, Tracheal Tube |
| Product Code | BSR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Tracheal Tube Stylet. |
| CFR Regulation Number | 868.5790 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Fragmentation | 29 |
Break | 21 |
Material Separation | 12 |
Failure To Adhere Or Bond | 8 |
Fracture | 5 |
Crack | 4 |
Device Markings / Labelling Problem | 4 |
Kinked | 3 |
Detachment Of Device Or Device Component | 3 |
Stylet | 3 |
Device Handling Problem | 2 |
Detachment Of Device Component | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Occlusion Within Device | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Material Puncture / Hole | 1 |
Contamination During Use | 1 |
Defective Component | 1 |
False Alarm | 1 |
Physical Resistance / Sticking | 1 |
Sticking | 1 |
Output Problem | 1 |
Cut In Material | 1 |
Device Or Device Fragments Location Unknown | 1 |
Failure To Disconnect | 1 |
Difficult To Advance | 1 |
Flaked | 1 |
| Total Device Problems | 116 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Brathwaites Oliver Medical | II | Oct-11-2016 |
| 2 | Cardinal Health | II | Feb-04-2015 |
| 3 | Teleflex Medical | II | Jun-14-2017 |
| 4 | Teleflex Medical | II | Nov-06-2015 |
| 5 | Vital Signs Colorado Inc. | II | Apr-30-2015 |