510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203614Substantially Equivalent

Monarch Bronchoscope

Auris Health, Inc., A Johnson and Johnson Family Company, Redwood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203614 is the FDA 510(k) clearance record for Monarch Bronchoscope, a class II device, cleared for Auris Health, Inc., A Johnson and Johnson Family Company on under FDA product code QNW (Reprocessed Bronchoscope). FDA's definition for product code QNW 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". FDA records list 2 510(k) clearances for Auris Health, Inc., A Johnson and Johnson Family Company, from to . As of , FDA records show no recalls naming K203614.

Clearance record

Decision date
Received
(91 days to decision)
Product code
QNW Reprocessed Bronchoscope
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Auris Health, Inc., A Johnson and Johnson Family Company 150 Shoreline Dr., Redwood CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNW

Trailing 12 months

FDA records hold no clearances under product code QNW in the trailing twelve months.

FDA records show no clearances under product code QNW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260