TruDi NAV Suction
TruDi NAV Suction is a reusable navigated instrument for evacuating gases, liquids and fragments during ENT and skull-base surgery. It works with the TruDi Navigation System to guide the…
TruDi NAV Suction is a reusable navigated instrument for evacuating gases, liquids and fragments during ENT and skull-base surgery. It works with the TruDi Navigation System to guide the tip to target anatomy.
A single-axis electromagnetic sensor is integrated at the distal tip. The navigation system displays its position and orientation in real time over the patient’s preoperative CT images for confirmation before use.
Listed Item
TruDi NAV Suction, 70° – 1PK
Angles and Connection
The instruments are offered in 0-degree, 70-degree and 90-degree forms. A sterile, single-use TruDi NAV Cable connects them to the navigation system, while the suction instruments themselves are reusable.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Acclarent, Inc., United States |
|---|---|
| FDA product code | PGW |
| Device type | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K180948 |
| Record published | 2019-01-20 |
| Record revised | 2024-11-21 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TDNS070Z | In distribution | |
| TDNS000Z | In distribution | |
| TDNS090Z | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ear, Nose, And Throat Stereotaxic Instrument | Karl Storz GmbH & Co. KG | 17 |
| StealthStation | Medtronic Navigation, Inc. | 17 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 14 |
| Ear, Nose, And Throat Stereotaxic Instrument | Medtronic Navigation, Inc. | 13 |
| Ear, Nose, And Throat Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 12 |
| StealthStation Cranial Software | Medtronic Navigation, Inc. | 11 |
| AxiEM™ | Medtronic Navigation, Inc. | 10 |
| Profess | Stryker Leibinger Gmbh & Co. KG | 8 |
| TGS | Stryker GmbH | 6 |
| StealthStation S8 | Medtronic Navigation, Inc. | 5 |
| TruDi Probe | Acclarent, Inc. | 4 |
| TruDi Shaver Blade | Acclarent, Inc. | 4 |
Showing 12 of 94. All products under Ear, Nose, And Throat Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231862 | 2023-07-21 |
| K221037 | 2022-07-20 |
| K201174 | 2020-08-12 |
| K193453 | 2020-03-23 |
| K190532 | 2019-05-03 |
| K180948 | 2018-07-20 |
| K173628 | 2018-03-10 |
| K161697 | 2016-10-24 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2024-07-09 | Class II | Process control | 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 | 265 units |
| Acclarent, Inc. | 510(k) number | 2021-11-12 | Class II | Process control | 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 | 1543 |
| Acclarent, Inc. | 510(k) number | 2019-03-06 | Class II | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. | 14 Suction Insstruments |
| Acclarent, Inc. | 510(k) number | 2019-03-06 | Class II | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. | |
| Acclarent, Inc. | 510(k) number | 2019-03-06 | Class II | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-09-21 | Class II | Software Design Change | When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT s | 141 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.