510(k) · Cleared
ClearedThe Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell
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 Oct 8, 2014 as substantially equivalent to K133573 (Fiagon GmbH, 2014) and 2 other predicates after a 128-day review. Its family tree reaches back 4 generations to 1994. 3 of the 29 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Oct 8, 2014
- Review
- 128 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K911783 (1994). 15 ancestors in all, the oldest K871046 (1987). 13 later devices descend from it, 6 citing it directly. 3 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 3 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 2 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 1 generation backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- This deviceK141456 The Fiagon Navigation - Extended Instrument Set Ent…Fiagon GmbH · 2014
- Descendant · cites it directly · 3 of its ownK171661 Scopis Extended Instrument Set EMScopis GmbH · 2017
- Descendant · cites it directly · 3 of its ownK161697 Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK160369 GuideWireFiagon GmbH · 2016
- Descendant · 2 generations on · 2 of its ownK161940 Guidewire 0.6 Single UseFiagon GmbH · 2016
- Descendant · 2 generations on · 1 of its ownK193118 TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K171661Scopis Extended Instrument Set EMScopis GmbH · 2017 · cites it directly3descendants
- K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. · 2016 · cites it directly3descendants
- K160369GuideWireFiagon GmbH · 2016 · cites it directly3descendants
- K161940Guidewire 0.6 Single UseFiagon GmbH · 2016 · 2 generations on2descendants
- K193118TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −3 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −2 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −1 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| 0 (this device) | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | Fiagon GmbH | 2014 | — |
| +1 | K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017 | — |
| +1 | K161697 | Acclarent NavWire Sinus Navigation Guidewire | Acclarent, Inc. | 2016 | — |
| +1 | K160369 | GuideWire | Fiagon GmbH | 2016 | — |
| +2 | K161940 | Guidewire 0.6 Single Use | Fiagon GmbH | 2016 | — |
| +2 | K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020 | — |
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 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K133573 | Fiagon Navigation SystemSummary page 4…Purpose of Submission The purpose of this submission is to gain clearance for a new set of instruments for the Image Guided Surgery System, Fiagon Navigation system (K133573). 4. Predicate Device Information The Fiagon Navigation System described in this submission is substantially equivalent t… | 2014 |
| * | K133665 | Malleable Suction InstrumentsSummary page 4…510(k) No. 1 Fiagon Navigation System Fiagon GmbH K133573 2 Malleable Suction™ Instruments Medtronic K133665 Navigation, Inc. 3 Instatrak® Visualization… | 2014 |
| * | K960330 | InstatrakSummary page 4…Medtronic K133665 Navigation, Inc. 3 Instatrak® Visualization K960330 Technology, Inc. 5. Device Description The Fiagon Navigation -… | 1996 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171661 | Scopis Extended Instrument Set EM | 2017 | 3 |
| K161697 | Acclarent NavWire Sinus Navigation Guidewire | 2016 | 3 |
| K160369 | GuideWire | 2016 | 3 |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | 2020 | 0 |
| K163416 | Fiagon Navigation – PointerTube Straight and PointerTube Keat | 2017 | 0 |
| K160479 | PointerShell Universal, PointerShell LS | 2016 | 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.
- K960330InstatrakVisualization Technology, Inc. · 1996 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 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.
- 6 of the 15 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K171661 (Scopis GmbH, 2017) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K133573.
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 – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation – Extended Instrument Set ENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure…
Read the full statement (131 words)
The Fiagon Navigation – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.
The Fiagon Navigation – Extended Instrument Set ENT 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, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
Skull base procedures for ENT access
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141456
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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