Reprocessed Bronchoscope
The Reprocessed Bronchoscope is a reprocessed single-use bronchoscope used for visualization and procedures within the airways and bronchi, equivalent to the original EOQ bronchoscope classification except that it has undergone reprocessing. Reprocessing validation data must be included in any 510(k) submission for this device type. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 874.4680 in the Ear, Nose, Throat specialty. It carries product code QNW and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QNW
- Device Class
- FDA class 2
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231473 | Monarch Bronchoscope | Nov 28, 2023 | Substantially Equivalent | Auris Health, Inc., A Johnson and Johnson Family Company |
| K203614 | Monarch Bronchoscope | Mar 11, 2021 | Substantially Equivalent | Auris Health, Inc., A Johnson and Johnson Family Company |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.