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510(k) K202609

Instrument Clamps Electromagnetic by Stryker Corporation — Product Code PGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2020
Date Received
September 9, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ear, Nose, And Throat Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
EN
Submission Type

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.

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