Forceps, Wire Closure, Ent, Non-Sterile

What Is This Device?

Prosthesis modification instrument for ossicular replacement surgery; see product code JXX.

How Is NNQ Classified?

Forceps, Wire Closure, Ent, Non-Sterile is FDA product code NNQ, Class 1, 21 CFR 874.3540.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.