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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hemostatic metal clip for the gi tract
Regulation Description Hemorrhoidal ligator.
Definition Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.
Product CodePKL
Regulation Number 876.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Deployment issue 69
Premature deployment 34
Failure to separate 25
Failure to advance 8
No Known Device Problem 7
Fracture 7
Material deformation 5
Migration of device or device component 2
Break 2
Detachment of device component 1
Failure to deploy 1
Peeled 1
Disinfection or Sterilization Issue at User Location 1
User used incorrect product for intended use 1
Difficult to remove 1
Device operates differently than expected 1
Total Device Problems 166

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