| Device Type ID | 146 |
| Device Name | Needle, Spinal, Short Term |
| Regulation Description | Anesthesia Conduction 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 | 868.5150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MIA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 146 |
| Device | Needle, Spinal, Short Term |
| Product Code | MIA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Anesthesia Conduction Needle. |
| CFR Regulation Number | 868.5150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SMITHS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITHS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 28 |
Protective Measures Problem | 14 |
Device Issue | 8 |
Needle | 8 |
Defective Device | 6 |
Manufacturing, Packaging Or Shipping Problem | 6 |
Product Quality Problem | 6 |
Defective Component | 6 |
Material Fragmentation | 4 |
Hub | 3 |
Difficult To Remove | 3 |
Retraction Problem | 2 |
Entrapment Of Device | 2 |
Device Damaged By Another Device | 2 |
Device Handling Problem | 2 |
Hole In Material | 1 |
Material Separation | 1 |
Positioning Problem | 1 |
| Total Device Problems | 103 |