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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device esophagoscope (flexible or rigid)
Regulation Description Esophagoscope (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 CodeEOX
Regulation Number 874.4710
Device Class 2


Premarket Reviews
ManufacturerDecision
CAPNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CYTED LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LUCID DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 3
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2022 1 1
2023 12 12
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 15 15
Break 2 2
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 15 15
No Clinical Signs, Symptoms or Conditions 1 1
Injury 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LLC II Aug-02-2023
2 Lucid Diagnostics, Inc. II May-24-2024
3 Olympus Corporation of the Americas II Sep-24-2021
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