| Device Type ID | 29 |
| Device Name | Needle, Emergency Airway |
| Regulation Description | Emergency Airway Needle. |
| 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) |
| CFR Regulation Number | 868.5090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BWC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 29 |
| Device | Needle, Emergency Airway |
| Product Code | BWC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Emergency Airway Needle. |
| CFR Regulation Number | 868.5090 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Collapse | 3 |
Break | 2 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Unintended Movement | 1 |
Material Separation | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 9 |