1 device · 1 company · 2023
Product code PGW: Ear, Nose, And Throat Stereotaxic Instrument
1 device under product code PGW, 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Ear, Nose, And Throat Stereotaxic Instrument. 21 CFR 882.4560, Class II. 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. MAUDE held 1,756 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| ENT EMK223734 · 510(k) | Brainlab AG | Neurology | database entry |
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