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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reprocessed bronchoscope
Regulation Description Bronchoscope (flexible or rigid) and accessories.
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.
Product CodeQNW
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
AURIS HEALTH, INC., A JOHNSON AND JOHNSON FAMILY COMPANY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 7 7
2023 1 2
2024 8 8
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
No Display/Image 4 5
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 3 3
Poor Quality Image 2 3
Difficult to Remove 1 2
Positioning Failure 1 1
Material Twisted/Bent 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 13
Pneumothorax 4 4
Laceration(s) of Esophagus 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Auris Health, Inc II Nov-19-2025
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