StealthStation System with Cranial Software— 510(k) K153660
Substantially EquivalentMedtronic Navigation, Inc.
FDA 510(k) clearance K153660 for StealthStation System with Cranial Software, Substantially Equivalent on 2016-09-14. Applicant: Medtronic Navigation, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Navigation, Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Recent devices under product code HAW
view allMore clearances from Medtronic Navigation, Inc.
view allAdverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K153660
K-number listed on FDA's recall record- Z-1666-2023 — StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
- Z-1995-2020 — Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.
- Z-0552-2019 — StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is an accessory to your StealthStation System. . . The Biopsy Needle is a presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153660.
Data sourced from openFDA. This site is unofficial and independent of the FDA.