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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, germicide, cleaning, for endoscopes
Definition High level disinfection of reusable, heat-sensitive devices 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 CodeNZA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 4 4
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 3 3
Device Emits Odor 3 3
Smoking 2 2
Fluid/Blood Leak 2 2
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 2 2
Headache 1 1
No Consequences Or Impact To Patient 1 1

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