Ear, Nose, and Throat Stereotaxic Instrument

What Is This Device?

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.

How Is PGW Classified?

Ear, Nose, And Throat Stereotaxic Instrument is FDA product code PGW, Class 2, 21 CFR 882.4560.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 17 recalls under this product code since 2017. None was by a company in China. The root causes the FDA records most often are Device Design (12), Process control (2) and Software Manufacturing/Software Deployment (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.