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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, biopsy, bronchoscope (non-rigid)
Regulation Description Bronchoscope (flexible or rigid) and accessories.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeBWH
Regulation Number 874.4680
Device Class 2

Device Problems
Adverse Event Without Identified Device or Use Problem 2
Cable break 1
Detachment Of Device Component 1
Mechanical Problem 1
Total Device Problems 5


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