Injector, Pen
The Pen Injector is a non-electrically-powered, mechanically operated device that provides accurate dosing of medicinal products from a cartridge, reservoir, or syringe through a manually inserted single-lumen hypodermic needle. It can be used by healthcare professionals or for patient self-injection. This is an FDA Class 2 device regulated under 21 CFR 880.5860 in the General Hospital specialty, with product code NSC, requiring 510(k) clearance. It is not an implant and does not provide life-sustaining support.
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Basic Information
- Product Code
- NSC
- Device Class
- FDA class 2
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K063151 | HUMAPEN LUXURA HD | Jan 09, 2007 | Substantially Equivalent | Eli Lilly and Co. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.