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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope, neurological
Regulation Description Neurological endoscope.
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 CodeGWG
Regulation Number 882.1480
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ SE & CO KG
  SUBSTANTIALLY EQUIVALENT 2
MAUNA KEA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Adverse Event Without Identified Device or Use Problem 11
Device Operates Differently Than Expected 11
Leak / Splash 8
Break 7
Mechanical Problem 6
Out-Of-Box Failure 5
Complete Blockage 5
Device Operational Issue 5
Poor Quality Image 5
Material Protrusion / Extrusion 3
Defective Device 3
Fluid Leak 2
Aspiration Issue 2
Appropriate Term/Code Not Available 2
Image Resolution Poor 2
Device Difficult to Setup or Prepare 2
Device Damaged Prior to Use 2
Failure to Conduct 2
Material Fragmentation 2
Pumping Problem 2
Kinked 1
Disconnection 1
Defective Component 1
Solder Joint Fracture 1
Device-Device Incompatibility 1
Device Misassembled During Manufacturing / Shipping 1
Display or Visual Feedback Problem 1
Overheating of Device 1
Inadequate User Interface 1
Decrease in Suction 1
Difficult to Remove 1
Date/Time-Related Software Problem 1
Material Integrity Problem 1
Loss of Power 1
Use of Device Problem 1
Vibration 1
Arcing of Electrodes 1
Material Disintegration 1
Material Deformation 1
Device Handling Problem 1
Material Rupture 1
Material Separation 1
Balloon 1
Loss of or Failure to Bond 1
Detachment Of Device Component 1
False Positive Result 1
Material Puncture / Hole 1
Failure to Disconnect 1
Failure to Deliver Energy 1
Total Device Problems 116

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Mar-20-2017
2 Karl Storz Endoscopy II Aug-28-2019

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