DeviceClearance

Product code QNW— Ear, Nose, Throat

Monarch Bronchoscope

Classification name
Reprocessed Bronchoscope
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QNW under 21 CFR 874.4680, via openFDA

Market context for product code QNW

FDA has cleared 2 devices under product code QNW between 2021 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNW

Recent clearances under product code QNW

Data sourced from openFDA. This site is unofficial and independent of the FDA.