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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
  1.  K102244  RELIANCE ENDOSCOPE PROCESSING SYSTEM
  2.  K110453  RELIANCE ENDOSCOPE PROCESSING SYSTEM
  3.  K123768  RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
  4.  K200989  Reliance Endoscope Processing System
  5.  K220361  Reliance EPS Endoscope Processing System and Relia ...
  6.  K230560  enspire 300 Series Automated Endoscope Reprocessor ...
  7.  K232918  enspire 300 Series Automated Endoscope Reprocessor
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
  1.  K102244  RELIANCE ENDOSCOPE PROCESSING SYSTEM
  2.  K110453  RELIANCE ENDOSCOPE PROCESSING SYSTEM
  3.  K123768  RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
  4.  K200989  Reliance Endoscope Processing System
  5.  K220361  Reliance EPS Endoscope Processing System and Relia ...
  6.  K230560  enspire 300 Series Automated Endoscope Reprocessor ...
  7.  K232918  enspire 300 Series Automated Endoscope Reprocessor

MDR Year MDR Reports MDR Events
2014 6 6
2015 10 10
2016 21 21
2017 9 9
2018 8 8
2019 2 2
2020 1 1
2021 4 4
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 17 17
Device Emits Odor 14 14
Leak/Splash 13 13
Device Operates Differently Than Expected 7 7
Smoking 5 5
Detachment Of Device Component 4 4
Residue After Decontamination 2 2
Device Displays Incorrect Message 2 2
Patient-Device Incompatibility 1 1
Chemical Problem 1 1
Connection Problem 1 1
Disconnection 1 1
Fire 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult to Open or Close 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 42 42
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 3 3
Headache 2 2
Irritation 1 1
Foreign Body In Patient 1 1
Fall 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Sep-20-2013
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