510(k) · Cleared
ClearedPointerShell Universal, PointerShell LS
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 Mar 23, 2016 as substantially equivalent to K141456 (Fiagon GmbH, 2014) after a 30-day review. Its family tree reaches back 5 generations to 1994. 3 of the 17 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 23, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911783 (1994). 16 ancestors in all, the oldest K871046 (1987). No later device cites it as a predicate yet. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 4 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 3 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 2 generations backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- 1 generation backK141456 The Fiagon Navigation - Extended Instrument Set Ent…Fiagon GmbH · 2014
- This deviceK160479 PointerShell Universal, PointerShell LSFiagon GmbH · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −4 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −3 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −2 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| −1 | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | Fiagon GmbH | 2014 | — |
| 0 (this device) | K160479 | PointerShell Universal, PointerShell LS | Fiagon GmbH | 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 |
| 2013 | 1 | 0 |
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Summary page 4…Surgery. The instruments involved in this submission are a modified version of instruments that have been approved within Fiagon Navigation extended instrument Set ENT (K141456). 4. Predicate Device Information The device described in this submission is substantially equivalent to the following com… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ in the 1996 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
- 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 22 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 16 ancestors have a recall of any class; 3 have a Class I recall.
- 5 other devices also cite its predicate K141456.
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. 2016, 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 PointerShell Universal and PointerShell LS are 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. Both the instruments are 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…
Read the full statement (124 words)
The PointerShell Universal and PointerShell LS are 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.
Both the instruments are 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.
ENT related anterior skull base procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160479: PointerShell Universal, PointerShell LS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160479
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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