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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)
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
ADN INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CAPNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
COGENTIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LUCID DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2

MDR Year MDR Reports MDR Events
2017 1 1
2020 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Sep-24-2021
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