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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

Device Problems
Imprecision 11
Device stops intermittently 4
Communication or transmission issue 3
Device operates differently than expected 3
Device displays error message 1
Bent 1
Application interface becomes non-functional or program exits abnormally 1
Total Device Problems 24