Injector, Pen

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown