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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer.
Technical Method The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor.
Target Area Ear, nose and throat
Regulation Medical Specialty Neurology
Review Panel Ear Nose & Throat
Product CodePGW
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible