Definition: A Pen Injector Is A Device That Provides A Nonelectrically-powered, Mechanically-operated Method Of Accurately Injecting A Dose Of Medicinal Product From A Medicinal Cartridge, Reservoir, Or Syringe Through A Manually-inserted Single Lumen Hypodermic
| Device Type ID | 2698 |
| Device Name | Injector, Pen |
| Regulation Description | Piston Syringe. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NSC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2698 |
| Device | Injector, Pen |
| Product Code | NSC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Piston Syringe. |
| CFR Regulation Number | 880.5860 [🔎] |
| Device Problems | |
|---|---|
Break | 22 |
Needle | 17 |
Rod | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Use Of Device Problem | 2 |
Device Operates Differently Than Expected | 2 |
Device Handling Problem | 2 |
Mechanical Jam | 1 |
Sticking | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Difficult Or Delayed Activation | 1 |
Insufficient Information | 1 |
Mechanical Problem | 1 |
Inaccurate Delivery | 1 |
Incorrect Or Inadequate Test Results | 1 |
Defective Device | 1 |
Human-Device Interface Problem | 1 |
Device Component Or Accessory | 1 |
Unexpected Therapeutic Results | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Component Missing | 1 |
Screw | 1 |
Device Difficult To Setup Or Prepare | 1 |
Material Puncture / Hole | 1 |
High Test Results | 1 |
| Total Device Problems | 69 |