TruDi Curette
FDA 510(k) K201174 · Acclarent, Inc.
510(k) numberK201174
Submission
- Device name
- TruDi Curette
- Applicant
- Acclarent, Inc.
Irvine, CA, US - Received
- May 1, 2020
- Decision date
- August 12, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGW – Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
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| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | Medtronic Navigation, Inc. | 03/16/2026SE |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC)PGW · Traditional | Claronav | 06/20/2025SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | Acclarent, Inc. | 07/21/2023SE |
| K223734 | ENT EmPGW · Traditional | Brainlab AG | 04/27/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | Acclarent, Inc. | 07/20/2022SE |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…PGW · Traditional | Stryker Corporation | 07/12/2022SE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | Fiagon GmbH | 07/19/2021SE |
| K202609 | Instrument Clamps ElectromagneticPGW · Special | Stryker Corporation | 10/09/2020SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | 02/19/2026SE |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation SystemPNZ · Traditional | 12/13/2023SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | 07/21/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | 07/20/2022SE |
| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | 08/27/2020SE |
| K193453 | TruDi ProbePGW · Traditional | 03/23/2020SE |
| K190532 | TruDi NAV WirePGW · Traditional | 05/03/2019SE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | 05/03/2019SE |
| K183090 | Relieva Tract Balloon Dilation SystemQGK · Traditional | 04/19/2019SE |
| K180948 | TruDi NAV Suction InstrumentsPGW · Traditional | 07/20/2018SE |
Questions and answers
When was TruDi Curette cleared by the FDA?
TruDi Curette (K201174) received a 510(k) decision of Substantially Equivalent on August 12, 2020, 103 days after the submission was received.
What is the product code of K201174?
The FDA product code is PGW – Ear, Nose, And Throat Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.