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TruDi NAVWIRE TDNW001

by Acclarent, Inc.

TruDi NAVWIRE TDNW001 is a Class II device made by Acclarent, Inc., cleared under FDA 510(k) K190532 on 3 May 2019 and listed in FDA GUDID since 20 Oct 2019 (UDI-DI 10705031245907), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K190532

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031245907 UDI-DI Date20 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190532 Date3 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190532 decided 3 May 2019 Active
  • FDA GUDID UDI-DI 10705031245907 listed 20 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190532
  2. Listed FDA GUDID 10705031245907

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TruDi NAVWIRE
Generic name
Paranasal sinus guidewire
Model / Ref / Catalog
TDNW001
Primary DI / UDI-DI
10705031245907
510(k) Number
FDA product code
PGW
GMDN term
Paranasal sinus guidewire
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Paranasal sinus guidewire

Cleared under the same submission (K190532)

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. →

Properties

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