Product code QNW

Device name

Reprocessed Bronchoscope

Medical specialty

Ear, Nose, Throat

Device class

2

Regulation number

874.4680

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Same as EOQ except reprocessed. Please see EOQ at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EOQ Reprocessing validation data for this device type must be included in a 510(k) submission.

Source

FDA openFDA device classification dataset