Home › Device types › PGW
Ear, Nose, And Throat Stereotaxic Instrument
FDA product code PGW · Class 2 · Neurology
289
Registered devices
1,712
Adverse events
17
Recalls
37
510(k) clearances
Devices with this code
Starlink Suction Tube Frazier-Tip 45° Angled 10 FR — Brainlab SEStealthStation S8 — MEDTRONIC NAVIGATION, INC.PointerShell 5 mm — Fiagon GmbHn/a — Stryker Leibinger GmbH & Co. KGFlexPointer — Fiagon GmbHStealthStation — MEDTRONIC NAVIGATION, INC.NOVA Basic — Scopis GmbHn.a. — Karl Storz GmbH & Co. KGFlexTube 4 mm — Fiagon GmbHNA — MEDTRONIC NAVIGATION, INC.ACCLARENT PIVOT — ACCLARENT, INC.Curve Navigation — Brainlab SEn/a — Stryker Leibinger GmbH & Co. KGNOVA AR — Scopis GmbHN/A — MEDTRONIC NAVIGATION, INC.Medtronic Navigation — MEDTRONIC NAVIGATION, INC.FlexPointer 1.5 single use — Fiagon GmbHMedtronic Navigation — MEDTRONIC NAVIGATION, INC.StealthStation — MEDTRONIC NAVIGATION, INC.Localizer Adhesive Pad C-Type — Fiagon GmbHn.a. — Karl Storz GmbH & Co. KGStealthStation — MEDTRONIC NAVIGATION, INC.n/a — Stryker Leibinger GmbH & Co. KGEM Patient Reference — Brainlab SE
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-03 | Integra LifeSciences Corp. (NeuroSciences) | It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tr |
| 2024-07-09 | Integra LifeSciences Corp. | Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepa |
| 2024-04-04 | Stryker Leibinger GmbH & Co. KG | Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference po |
| 2023-09-21 | Acclarent, Inc. | When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intend |
| 2021-11-12 | Acclarent, Inc. | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient |
| 2019-03-06 | Acclarent, Inc. | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| 2019-03-06 | Acclarent, Inc. | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| 2019-03-06 | Acclarent, Inc. | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| 2017-06-29 | Medtronic Navigation, Inc. | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| 2017-06-29 | Medtronic Navigation, Inc. | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.