510(k) · Cleared
ClearedStealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Jun 26, 2020 as substantially equivalent to K170018 (Medtronic Navigation, Inc., 2017) and 1 other predicate after a 99-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 26, 2020
- Review
- 99 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001284 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 2 generations backK153247 Fusion Compact Navigation SystemMedtronic Navigation, Inc. · 2016
- 1 generation backK170018 StealthStationTM S8 ENT SoftwareMedtronic Navigation, Inc. · 2017
- This deviceK200723 StealthStation FlexENT (9736242), StealthStation S8 ENT Software…Medtronic Navigation, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK253395 Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK223734 ENT EMBrainlab AG · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −2 | K153247 | Fusion Compact Navigation System | Medtronic Navigation, Inc. | 2016 | — |
| −1 | K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | 2017 | — |
| 0 (this device) | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc. | 2020 | — |
| +1 | K253395 | Stealth AXiS™ ENT clinical application | Medtronic Navigation, Inc. | 2026 | — |
| +1 | K223734 | ENT EM | Brainlab AG | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGW device
- #1 K261540 Cube 4D Navigation System, VirtuEye Proscore 13.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170018 | StealthStationTM S8 ENT SoftwareSummary page 7…be identified relative to images of the anatomy. IX. Identification of Legally Marketed Devices (Predicate Devices) Primary Predicate: K170018 - StealthStation™ S8 ENT Software 1.0 Predicate: K153247 - FUSION™ Compact X. Comparison of the Technological Charact… | 2017 |
| * | K153247 | Fusion Compact Navigation SystemSummary page 7…age 7 === IX. Identification of Legally Marketed Devices (Predicate Devices) Primary Predicate: K170018 - StealthStation™ S8 ENT Software 1.0 Predicate: K153247 - FUSION™ Compact X. Comparison of the Technological Characteristics Refer to the tables within this section for a c… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K253395 (Medtronic Navigation, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PGW devicesPGW Ear, Nose, And Throat Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PGW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGW
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGW
220in 2025
MAUDE reports naming product code PGW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 116 | 0 | 7 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 9 | 115 | 0 | 33 |
| 2017 | 4 | 125 | 0 | 42 |
| 2018 | 2 | — | 0 | 96 |
| 2019 | 1 | — | 3 | 247 |
| 2020 | 8 | 100 | 0 | 161 |
| 2021 | 1 | — | 1 | 190 |
| 2022 | 2 | — | 0 | 166 |
| 2023 | 2 | — | 1 | 200 |
| 2024 | 0 | — | 0 | 274 |
| 2025 | 1 | — | 1 | 220 |
| 2026 | 3 | 65 | 0 | — |
What is it indicated for?
The StealthStation FlexENT™ System, with the StealthStation™ ENT Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. This can include, but is not…
Read the full statement (156 words)
The StealthStation FlexENT™ System, with the StealthStation™ ENT Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
Functional Endoscopic Sinus Surgery (FESS)
Endoscopic Skull Base procedures
Lateral Skull Base procedures
The Medtronic StealthStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200723 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200723: StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200723
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026