510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NSCClass II

Injector, Pen

21 CFR 880.5860 / General Hospital
FDA source (opens on fda.gov)

NSC is the FDA product code for Injector, Pen, a class II device type, regulated under 21 CFR 880.5860. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NSC
Device name
Injector, Pen
FDA 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.
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NSC

By decision year
1 clearance under product code NSC with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NSC by decision year
YearClearances
20071

Applicants with the most clearances

Product code NSC
Applicants holding the most 510(k) clearances under product code NSC
ApplicantClearances
Eli Lilly and Company, Pharmaceutical Delivery Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order