510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QNWClass II

Reprocessed Bronchoscope

21 CFR 874.4680 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QNW is the FDA product code for Reprocessed Bronchoscope, a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QNW
Device name
Reprocessed Bronchoscope
FDA 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.
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code QNW

By decision year
2 clearances under product code QNW with a decision year between 2021 and 2023, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QNW by decision year
YearClearances
20211
20231

Applicants with the most clearances

Product code QNW
Applicants holding the most 510(k) clearances under product code QNW
ApplicantClearances
Auris Health, Inc., A Johnson and Johnson Family Company2

Companies listing this code with FDA

Companies whose registered establishments list this code