# Ear, Nose, And Throat Stereotaxic Instrument
> **Product code: PGW** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560
## Classification
- **FDA Product Code:** PGW
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.4560
- **Review panel:** EN
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 36
- **Registered establishments:** 46
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PGW)
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