510(k) · Cleared
ClearedTGS Guidewire and updated Scopis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Ent · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Feb 21, 2020 as substantially equivalent to K161940 (Fiagon GmbH, 2016) and 2 other predicates after a 101-day review. Its family tree reaches back 7 generations to 1994. 4 of the 30 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Feb 21, 2020
- Review
- 101 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K911783 (1994). 28 ancestors in all, the oldest K871046 (1987). 1 later device descends from it, 1 citing it directly. 4 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 6 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 5 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 4 generations backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- 3 generations backK141456 The Fiagon Navigation - Extended Instrument Set Ent…Fiagon GmbH · 2014
- 2 generations backK160369 GuideWireFiagon GmbH · 2016
- 1 generation backK161940 Guidewire 0.6 Single UseFiagon GmbH · 2016
- This deviceK193118 TGS Guidewire and updated Scopis SoftwareStryker Ent · 2020
- Descendant · cites it directly · 0 of its ownK221098 Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning…Stryker Corporation · 2022 · Recalled
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −6 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −5 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −4 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| −3 | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | Fiagon GmbH | 2014 | — |
| −2 | K160369 | GuideWire | Fiagon GmbH | 2016 | — |
| −1 | K161940 | Guidewire 0.6 Single Use | Fiagon GmbH | 2016 | — |
| 0 (this device) | K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020 | — |
| +1 | K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software… | Stryker Corporation | 2022 | 1 |
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 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
4 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 |
|---|---|---|---|
| * | K161940 | Guidewire 0.6 Single UseSummary page 4…Devices: Predicate Device Manufacturer 510(k) No. Guidewire 0.6 Single Use Fiagon GmbH K161940 Scopis Extended Instrument Set EM Scopis GmbH K171661 Stryker ENT Navigation System EM… | 2016 |
| * | K171661 | Scopis Extended Instrument Set EMSummary page 4…510(k) No. Guidewire 0.6 Single Use Fiagon GmbH K161940 Scopis Extended Instrument Set EM Scopis GmbH K171661 Stryker ENT Navigation System EM Scopis GmbH K161491 Device Description: The TGS Guidewire is a si… | 2017 |
| * | K161491 | Scopis Hybrid Navigation System EMSummary page 4…K161940 Scopis Extended Instrument Set EM Scopis GmbH K171661 Stryker ENT Navigation System EM Scopis GmbH K161491 Device Description: The TGS Guidewire is a single use, sterile, disposable instrument intended to be used with the Stryker ENT N… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software… | 2022 | 0 |
Has anything in its family been recalled? (4 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.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 28 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K221098 (Stryker Corporation, 2022) 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 TGS Guidewire 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:
+ Transsphenoidal access procedures
+ Intranasal procedures
+ Sinus procedures, such as maxillary antrostomies, ethmoidectomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies
* ENT-related anterior skull base procedures
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/K193118 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193118: TGS Guidewire and updated Scopis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193118
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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