# K180948: TruDi NAV Suction Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Jul 20, 2018 after 100 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911783 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
3 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161555: KARL STORZ NAV1 Electromagnetic Navigation System, Karl Storz Endoscopy America, Inc. (2016) Summary page 4.
- K153555: EM ENT Navigated Suctions, Medtronic Navigation, Inc. (2016) Summary page 4.

## Recalls of this device
- Jul 9, 2024 · Class II · Z-2507-2024: 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 t
- Nov 12, 2021 · Class II · Z-0415-2022: 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
- Mar 6, 2019 · Class II · Z-0824-2020: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
- Mar 6, 2019 · Class II · Z-0825-2020: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
- Mar 6, 2019 · Class II · Z-0826-2020: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

## Indications for use
TruDi™ NAV Suction Instruments are intended for use with the TruDi™ Navigation System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the instruments to the targeted anatomy, and evacuation of gases, liquids, and fragments. TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.

Source page: https://510kreport.com/device/K180948
Methodology: https://510kreport.com/methodology