KLZ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Tube, Shunt, Endolymphatic With Valve

Device class

Class II (moderate risk)

Regulation

21 CFR 874.3850

Medical specialty

Ear, Nose, Throat

Flags

Implant

Adverse events (MAUDE)

1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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