# Injector, Pen
> **Product code: NSC** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5860
## Classification
- **FDA Product Code:** NSC
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.5860
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 15
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NSC)
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