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TruDi Probe

by Acclarent, Inc.

510(k) K193453

TruDi Probe 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) K193453 on 23 Mar 2020, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193453 Date23 Mar 2020ClearedStatusActive

Official records

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  • Withdrawn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 K193453

4 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 K193453
UDI-DISize and differences
TruDi Probe TDP0005
ACCLARENT, INC.
TDP0005 / TDP000510705031464193 —On the market
TruDi Probe TDP0005Z
ACCLARENT, INC.
TDP0005Z / TDP0005Z20705031464213 —On the market
TruDi Probe TDP0705
ACCLARENT, INC.
TDP0705 / TDP070510705031464209
Angle 70 deg
On the market
TruDi Probe TDP0705Z
ACCLARENT, INC.
TDP0705Z / TDP0705Z20705031464220
Angle 70 deg
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. →