FDA product code NSC: Injector, Pen
NSC is the FDA product code for injector, pen. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under NSC. The average 510(k) review took 85 days (median 85).
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 needle. The device can be used by health professionals or for self-injection by the patient.
Classification
| Field | Value |
|---|---|
| Device name | Injector, Pen |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NSC clearance
Top NSC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eli Lilly and Co. | 1 | 2007-01-09 |
Most recent NSC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063151 | Eli Lilly and Co. | HUMAPEN LUXURA HD | 2007-01-09 | 85 |
Recalls for NSC devices
openFDA lists no recalls for product code NSC.
Frequently asked questions
What is FDA product code NSC?
NSC is the FDA product code for injector, pen. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is NSC?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code NSC?
Across 1 cleared submissions the average was 85 days from receipt to decision (median 85).
Which companies have the most NSC clearances?
Eli Lilly and Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NSC
- Run a recall and safety report across every NSC manufacturer
- Watch product code NSC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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