# TruDi Navigation System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/trudi-navigation-system-pgw>
- Manufacturer: [Biosense Webster](https://devicerts.com/manufacturers/biosense-webster-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: PGW

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K192397 · decision 2020-01-30 · decision SESE · status: Active

## Recalls

- Z-0127-2024 · Class II · ongoing · initiated 2023-09-21: When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

## Identifiers

- 510(k) Number: K192397 [FDA 510(k)]
- FDA product code: PGW [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 882.4560 [FDA 510(k)]
- Advisory committee: Neurology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: TruDi Navigation System, Biosense Webster. deviCERTS medical device catalogue. https://devicerts.com/devices/trudi-navigation-system-pgw (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-10
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/trudi-navigation-system-pgw.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/trudi-navigation-system-pgw
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.