FDA product code KAZ: Rasp, Frontal-Sinus

KAZ is the FDA product code for rasp, frontal-sinus. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under KAZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameRasp, Frontal-Sinus
Device classClass I
Regulation21 CFR 874.4420
Review panelEN — Ear, Nose and Throat
Medical specialtyEar, Nose, Throat
Premarket route510(k) exempt

Recalls for KAZ devices

openFDA lists no recalls for product code KAZ.

Frequently asked questions

What is FDA product code KAZ?

KAZ is the FDA product code for rasp, frontal-sinus. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.

What device class is KAZ?

Class I, regulation 21 CFR 874.4420. 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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