StealthStation Cranial Software
SFW 9735762 APP Stealth S8 Application
3manufacturers in China registered for this device type
11catalogue numbers in this listing
6510(k) clearances naming this product code
8recalls on this code
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 | Medtronic Navigation, 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, Repacker / relabeller, Manufacturer |
| 510(k) | K170018 |
| Record published | 2018-02-09 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9735736 | In distribution | |
| 9735736 | In distribution | |
| 9735736 | In distribution | |
| 9735762 | In distribution | |
| 9735736 | In distribution | |
| 9735736 | In distribution | |
| 9735736 | In distribution | |
| 9735736 | In distribution | |
| 9735736 | In distribution | |
| 9735736 | In distribution | |
| 9735736 | 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 |
| 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 |
| Scopis | Stryker Leibinger Gmbh & Co. KG | 3 |
Showing 12 of 94. All products under Ear, Nose, And Throat Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253395 | 2026-03-16 |
| K200723 | 2020-06-26 |
| K170018 | 2017-05-19 |
| K153555 | 2016-04-07 |
| K153247 | 2016-02-18 |
| K133665 | 2014-03-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Navigation, Inc. | UDI-DI | 2024-08-22 | Class II | Software design | Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation – when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree | 1,801 systems |
Recalls
8 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 149 instruments | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 6 kits | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 8 kits | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 277 instruments | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 60 instruments | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 75 instruments | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 15 kits | 2018-08-03 |
| 2017-06-29 | Class II | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | 13 kits | 2018-08-03 |
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.