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TruDi NAV Suction Instruments

by Acclarent, Inc.

510(k) K180948

TruDi NAV Suction Instruments is a medical device (FDA Class II; FDA product code PGW, Ear, Nose, And Throat Stereotaxic Instrument) made by Acclarent, Inc., cleared under FDA 510(k) K180948 on 20 Jul 2018, active as of 11 Oct 2026. 5 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180948 Date20 Jul 2018ClearedStatusActive

Official records

Recalls

5 recalls · 2 ongoing · FDA

    • Ongoing Z-2507-2024 FDA Class II initiated 9 Jul 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 the visualized location displayed on the system.

    • Ongoing Z-0415-2022 FDA Class II initiated 12 Nov 2021

    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.

  • 3 recalls, same reason

    • Terminated Z-0824-2020 FDA Class II initiated 6 Mar 2019
    • Terminated Z-0825-2020 FDA Class II initiated 6 Mar 2019
    • Terminated Z-0826-2020 FDA Class II initiated 6 Mar 2019

    The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

Timeline

6 dated events

  1. Cleared FDA 510(k) K180948
  2. Recall initiated FDA recalls Z-0824-2020
  3. Recall initiated FDA recalls Z-0825-2020
  4. Recall initiated FDA recalls Z-0826-2020
  5. Recall initiated FDA recalls Z-0415-2022
  6. Recall initiated FDA recalls Z-2507-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PGW
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K180948

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K180948
UDI-DISize and differences
TruDi NAV Cable TDNC001
ACCLARENT, INC.
TDNC001 / TDNC00110705031245853
Single use: yes
On the market
TruDi NAV Cable TDNC001Z
ACCLARENT, INC.
TDNC001Z / TDNC001Z20705031245867
Single use: yes
On the market
TruDi NAV Suction TDNS000Z
ACCLARENT, INC.
TDNS000Z / TDNS000Z10705031245877
Single use: no
On the market
TruDi NAV Suction TDNS070Z
ACCLARENT, INC.
TDNS070Z / TDNS070Z10705031245884
Single use: no
On the market
TruDi NAV Suction TDNS090Z
ACCLARENT, INC.
TDNS090Z / TDNS090Z10705031245891
Single use: no
On the market
TruDi® TDNC001
ACCLARENT, INC.
TDNC001 / TDNC00110381780544081
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code PGW (Ear, Nose, And Throat Stereotaxic Instrument).

Other devices from Acclarent, Inc.

See all devices from Acclarent, Inc. →