QNW — Reprocessed Bronchoscope Class II

FDA Device Classification

FDA product code QNW covers "Reprocessed Bronchoscope", a Class II medical device regulated under 21 CFR 874.4680. Submissions are reviewed by the Ear, Nose, Throat panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
QNW
Device Class
Class II
Regulation Number
874.4680
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231473auris health, inc., a johnson and johnson familyMonarch BronchoscopeNovember 28, 2023
K203614auris health, inc., a johnson and johnson familyMonarch BronchoscopeMarch 11, 2021