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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device instrument, ent manual surgical
Regulation Description Ear, nose, and throat manual surgical instrument.
Product CodeLRC
Regulation Number 874.4420
Device Class 1


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 6
ENTELLUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ENTELLUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTUIT MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SINUSYS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 41
Detachment of Device or device Component 14
Material Separation 12
Material Rupture 11
Break 7
Material Fragmentation 6
Material Frayed 6
Scratched Material 5
Unsealed Device Packaging 5
Detachment Of Device Component 5
Bent 4
Use of Device Problem 4
Tip 4
Fracture 4
Imprecision 4
Material Integrity Problem 3
Deflation Problem 3
Tear, Rip or Hole in Device Packaging 3
Crack 2
Flaked 2
Improper or Incorrect Procedure or Method 2
Contamination / decontamination Problem 1
Infusion or Flow Problem 1
Temperature Problem 1
Material Split, Cut or Torn 1
Loose or Intermittent Connection 1
Contamination During Use 1
Off-Label Use 1
Device Markings / Labelling Problem 1
Balloon 1
Device Damaged by Another Device 1
Packaging Problem 1
Sticking 1
Jaw 1
Device Expiration Issue 1
Mechanical Problem 1
Device Contamination with Chemical or Other Material 1
Positioning Problem 1
Insufficient Information 1
Failure to Advance 1
Device Issue 1
Failure to Unfold or Unwrap 1
Total Device Problems 168


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