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TruDi Probe TDP0005

by Acclarent, Inc.

TruDi Probe TDP0005 is a multi-purpose stereotactic surgery system (FDA Class II; FDA product code PGW, Ear, Nose, and Throat Stereotaxic Instrument) made by Acclarent, Inc., cleared under FDA 510(k) K193453 on 23 Mar 2020 and listed in FDA GUDID since 31 Jul 2020 (UDI-DI 10705031464193), 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) K193453

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 Number10705031464193 UDI-DI Date31 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193453 Date23 Mar 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193453 decided 23 Mar 2020 Active
  • FDA GUDID UDI-DI 10705031464193 listed 31 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193453
  2. Listed FDA GUDID 10705031464193

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TruDi Probe
Generic name
Multi-purpose stereotactic surgery system
Model / Ref / Catalog
TDP0005
Primary DI / UDI-DI
10705031464193
510(k) Number
FDA product code
PGW
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Multi-purpose stereotactic surgery system

Cleared under the same submission (K193453)

Similar devices in this category

Other devices filed under Multi-purpose stereotactic surgery system.

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)