510(k) · Cleared
ClearedFiagon Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiagon GmbH · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Apr 30, 2014 as substantially equivalent to K001284 (Medtronic Surgical Navigation Technologies, 2000) and 3 other predicates after a 161-day review. Its family tree reaches back 3 generations to 1994. 3 of the 41 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Apr 30, 2014
- Review
- 161 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K911783 (1994). 12 ancestors in all, the oldest K871046 (1987). 28 later devices descend from it, 8 citing it directly. 3 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 2 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 1 generation backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- This deviceK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- Descendant · cites it directly · 13 of its ownK141456 The Fiagon Navigation - Extended Instrument Set Ent…Fiagon GmbH · 2014
- Descendant · cites it directly · 4 of its ownK162176 Fiagon Navigation SystemFiagon GmbH · 2016
- Descendant · 2 generations on · 3 of its ownK171661 Scopis Extended Instrument Set EMScopis GmbH · 2017
- Descendant · cites it directly · 3 of its ownK161491 Scopis Hybrid Navigation System EMScopis GmbH · 2017
- Descendant · cites it directly · 3 of its ownK161701 CARTO ENT SystemBiosense Webster · 2016
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH · 2014 · cites it directly13descendants
- K162176Fiagon Navigation SystemFiagon GmbH · 2016 · cites it directly4descendants
- K171661Scopis Extended Instrument Set EMScopis GmbH · 2017 · 2 generations on3descendants
- K161491Scopis Hybrid Navigation System EMScopis GmbH · 2017 · cites it directly3descendants
- K161701CARTO ENT SystemBiosense Webster · 2016 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −2 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −1 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| 0 (this device) | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| +1 | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | Fiagon GmbH | 2014 | — |
| +1 | K162176 | Fiagon Navigation System | Fiagon GmbH | 2016 | — |
| +2 | K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017 | — |
| +1 | K161491 | Scopis Hybrid Navigation System EM | Scopis GmbH | 2017 | — |
| +1 | K161701 | CARTO ENT System | Biosense Webster | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 1 |
| 1998 | 2 | 2 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 8 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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.
3 devices in this family have a Class I recall. 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 12.9 · 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? (4)
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 |
|---|---|---|---|
| * | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking SystemSummary page 1…predicates: Predicate Device Manufacturer 510(k) No. 1 StealthStation® System Medtronic Surgical K001284 GoldenEyeTM Micro Magnetic Navigation Tracking System Technologies 2… | 2000 |
| * | K960330 | InstatrakSummary page 1…Micro Magnetic Navigation Tracking System Technologies 2 InstaTrak® Visualization K960330 (InstaTrak®3000) Technology, Inc. (K983529) 3 Regulus TM Navigator… | 1996 |
| * | K983529 | Instatrak 3000Summary page 1…Technologies 2 InstaTrak® Visualization K960330 (InstaTrak®3000) Technology, Inc. (K983529) 3 Regulus TM Navigator COMPASS K964229 ____ ________________________… | 1998 |
| * | K964229 | Regulus NavigatorSummary page 1…K960330 (InstaTrak®3000) Technology, Inc. (K983529) 3 Regulus TM Navigator COMPASS K964229 ____ ________________________ International Inc. 5. Device Description The Fiagon Navigatio… | 1997 |
What descends from it? (28)
See all 288 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | 2014 | 13 |
| K162176 | Fiagon Navigation System | 2016 | 4 |
| K161491 | Scopis Hybrid Navigation System EM | 2017 | 3 |
| K161701 | CARTO ENT System | 2016 | 3 |
| K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | 2016 | 2 |
| K150473 | FlexPointer 1.5 mm | 2015 | 2 |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | 2021 | 1 |
| K193502 | TGS Universal Headrest with Mounting Arm | 2020 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 12 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K141456 (Fiagon GmbH, 2014) has gone furthest, with 13 descendants of its own.
- 8 other devices also cite its predicate K001284.
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. 2014, 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 Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the…
Read the full statement (110 words)
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures;
Transphenoidal access procedures.
Intranasal procedures.
Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies,
Sphenoidiotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomides.
ENT related anterior skull base procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133573: Fiagon Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133573
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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