DeviceClearance

Product code NSC— General Hospital

HUMAPEN LUXURA HD

Classification name
Injector, Pen
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NSC under 21 CFR 880.5860, via openFDA

Market context for product code NSC

FDA has cleared 1 device under product code NSC, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NSC

Recent clearances under product code NSC

Data sourced from openFDA. This site is unofficial and independent of the FDA.