QNW · Class II · 21 CFR 874.4680

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.

2
Total
2
Cleared
141d
Avg days
2021
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Reprocessed Bronchoscope Devices (Product Code QNW)

2 devices
1–2 of 2
Cleared Nov 28, 2023
Monarch Bronchoscope
K231473
Auris Health, Inc., A Johnson and Johnson Family Company
Ear, Nose, Throat · 190d
Cleared Mar 11, 2021
Monarch Bronchoscope
K203614
Auris Health, Inc., A Johnson and Johnson Family Company
Ear, Nose, Throat · 91d

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.