FDA product code KLZ: Tube, Shunt, Endolymphatic With Valve

KLZ is the FDA product code for tube, shunt, endolymphatic with valve. It is a Class II device, regulated under 21 CFR 874.3850 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KLZ. The average 510(k) review took 880 days (median 880).

Classification

Compare with all 510(k) review times · Search every KLZ clearance

Top KLZ applicants

Most recent KLZ clearances

Recalls for KLZ devices

openFDA lists no recalls for product code KLZ.

Frequently asked questions

What is FDA product code KLZ?

KLZ is the FDA product code for tube, shunt, endolymphatic with valve. It is a Class II device, regulated under 21 CFR 874.3850 and reviewed by the Ear, Nose and Throat panel.

What device class is KLZ?

Class II, regulation 21 CFR 874.3850. Typical premarket route: 510(k).

How long does a 510(k) take for product code KLZ?

Across 1 cleared submissions the average was 880 days from receipt to decision (median 880).

Which companies have the most KLZ clearances?

A.Stein - Regulatory Affairs Consulting (1).

Next steps

• Run an FDA pathway report with predicate devices for product code KLZ
• Run a recall and safety report across every KLZ manufacturer
• Watch product code KLZ for new clearances and recalls

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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