FDA Product Code QNW: Reprocessed Bronchoscope
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.
Leading manufacturers include Auris Health, Inc., A Johnson and Johnson Family Company.
FDA 510(k) Cleared Reprocessed Bronchoscope Devices (Product Code QNW)
About Product Code QNW - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QNW since 2021, with 2 receiving FDA clearance (average review time: 141 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QNW devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →