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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, manual, specialized obstetric-gynecologic
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeKNA
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
FRONTLINE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GYNEX CORP.
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 5
Other (for use when an appropriate device code cannot be identified) 5
No Known Device Problem 4
Material separation 4
Balloon rupture 3
Material perforation 3
Fitting problem 2
Balloon burst 1
Component(s), broken 1
Fracture 1
Kinked 1
Difficult to remove 1
Material rupture 1
Device or device fragments location unknown 1
Balloon pinhole 1
Unable to confirm conditions of use 1
Dislodged or dislocated 1
No code available 1
Total Device Problems 37

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