NSC · Class II · 21 CFR 880.5860

FDA Product Code NSC: Injector, Pen

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.

Leading manufacturers include Eli Lilly and Co..

Total

Cleared

85d

Avg days

2007

Since

FDA 510(k) Cleared Injector, Pen Devices (Product Code NSC)

1 devices

1–1 of 1

General Hospital · 85d

About Product Code NSC - Regulatory Context

Related FDA 510(k) Regulatory Insights

What is a Predicate Device in FDA 510(k)?
What is an FDA Product Code?
What is 510(k) Clearance?
Browse all General Hospital FDA 510(k) clearances
FDA 510(k) regulatory consulting firms ranked by submission volume
FDA 510(k) submission cost and user fees FY 2026

Data Source

FDA 510(k) public files . 176,583 total devices indexed.

Latest clearance: Jan 09, 2007

Product Code Info

Code	NSC
Device class	Class II
CFR	21 CFR 880.5860
Panel	General Hospital

Verify on FDA.gov

View NSC classification on FDA.gov →