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TruDi® TDNC001

by Acclarent, Inc.

TruDi® TDNC001 is a Class II device made by Acclarent, Inc., cleared under FDA 510(k) K180948 on 20 Jul 2018 and listed in FDA GUDID since 15 Oct 2026 (UDI-DI 10381780544081), active as of 2 Nov 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K180948

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780544081 UDI-DI Date15 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180948 Date20 Jul 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180948 decided 20 Jul 2018 Active
  • FDA GUDID UDI-DI 10381780544081 listed 15 Oct 2026 Listed

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

7 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
  7. Listed FDA GUDID 10381780544081

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TruDi®
Generic name
Electromagnetic/optical surgical navigation/tracking system
Model / Ref / Catalog
TDNC001
Primary DI / UDI-DI
10381780544081
510(k) Number
FDA product code
PGW
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K180948)

and 1 more cleared under K180948

Other devices from Acclarent, Inc.

See all devices from Acclarent, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)