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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ear, nose, and throat stereotaxic instrument
Regulation Description Stereotaxic instrument.
Definition Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Product CodePGW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Imprecision 16
Device stops intermittently 8
Device operates differently than expected 8
Communication or transmission issue 6
Application interface becomes non-functional or program exits abnormally 4
Bent 2
Device displays error message 2
Material deformation 1
No Known Device Problem 1
Suction issue 1
Total Device Problems 49

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