# TruDi NAV Suction Instruments

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

- Canonical page: <https://devicerts.com/devices/trudi-nav-suction-instruments-pgw>
- Manufacturer: [Acclarent, Inc.](https://devicerts.com/manufacturers/acclarent-inc) (United States, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: PGW

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K180948 · decision 2018-07-20 · decision SESE · status: Active

## Recalls

- Z-2507-2024 · Class II · ongoing · initiated 2024-07-09: Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
- Z-0415-2022 · Class II · ongoing · initiated 2021-11-12: Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
- Z-0824-2020 · Class II · terminated · initiated 2019-03-06: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
- Z-0825-2020 · Class II · terminated · initiated 2019-03-06: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
- Z-0826-2020 · Class II · terminated · initiated 2019-03-06: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

## Identifiers

- 510(k) Number: K180948 [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 NAV Suction Instruments, Acclarent, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/trudi-nav-suction-instruments-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: 2026-10-11
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/trudi-nav-suction-instruments-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-nav-suction-instruments-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.