Home / Device Classification / QNW

QNW — Reprocessed Bronchoscope Class II

FDA Device Classification

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