510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Ear, Nose, And Throat Stereotaxic Instrument
Neurology
The Ear, Nose, and Throat Stereotaxic Instrument is a surgical navigation device intended to precisely locate surgical instruments within anatomical structures during open or percutaneous ENT procedures, using CT- or MR-based imaging models or digitized anatomical landmarks as reference. It is an FDA Class 2 device regulated under 21 CFR 882.4560, requiring 510(k) clearance, classified under Neurology (NE) with ENT (EN) panel review. The product code is PGW. This device is not implantable and does not sustain life.
510(k) Clearances
35 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.