KTR

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Tube, Aspirating, Bronchoscope, Rigid

Device class

Class II (moderate risk)

Regulation

21 CFR 874.4680

Medical specialty

Ear, Nose, Throat

FDA definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Adverse events (MAUDE)

1993: 1 · 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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