FDA product code NNV: Vise, Ossicular Finger, Non-Sterile

NNV is the FDA product code for vise, ossicular finger, non-sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel. Devices under NNV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

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

Classification

FieldValue
Device nameVise, Ossicular Finger, Non-Sterile
Device classClass I
Regulation21 CFR 874.3540
Review panelEN — Ear, Nose and Throat
Medical specialtyEar, Nose, Throat
Premarket route510(k) exempt
GMP exemptYes

Recalls for NNV devices

openFDA lists no recalls for product code NNV.

Frequently asked questions

What is FDA product code NNV?

NNV is the FDA product code for vise, ossicular finger, non-sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel.

What device class is NNV?

Class I, regulation 21 CFR 874.3540. Typical premarket route: 510(k) exempt.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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