QNW

Reprocessed Bronchoscope

Product code
QNW
Device name
Reprocessed Bronchoscope
Device class
Class 2
21 CFR
21 CFR 874.4680
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-11-28.

NumberDecision dateApplicantDevice nameSummary
K2314732023-11-28Auris Health, Inc., A Johnson and John…Monarch BronchoscopePDF

1 summaries are archived here for direct download.

Official FDA classification page: QNW
Classification and pathway per current FDA publications. Data from openFDA (CC0).