510(k) · Cleared
ClearedVenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiagon GmbH · PNZ Eustachian Tube Balloon Dilation Device
Cleared on May 26, 2023 as substantially equivalent to K163509 (Entellus Medical, Inc., 2017) and 2 other predicates after a 137-day review. Its family tree reaches back 21 generations to 1994.
- Decided
- May 26, 2023
- Review
- 137 days
- Class
- Class II
- Product code
- PNZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K936109 (1994). 117 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 17 generations between
- 3 generations backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- 2 generations backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- 1 generation backK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- This deviceK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
Show all 21 generations
- Root · 21 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 20 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 19 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 18 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 17 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 16 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 15 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 14 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 13 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 12 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 11 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 10 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 9 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 8 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 7 generations backK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- 6 generations backK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 5 generations backK121943 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 4 generations backK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
- 3 generations backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- 2 generations backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- 1 generation backK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- This deviceK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −20 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −19 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −18 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −17 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −16 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −15 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −14 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −13 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −12 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −11 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −10 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −9 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −8 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −7 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| −6 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −5 | K121943 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −4 | K132440 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2013 | — |
| −3 | K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014 | — |
| −2 | K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015 | — |
| −1 | K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | 2017 | — |
| 0 (this device) | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System… | Fiagon GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 8 | 0 |
| 1996 | 11 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 2 | 0 |
| 2000 | 12 | 0 |
| 2001 | 3 | 0 |
| 2002 | 8 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 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.
Planning a device in PNZ? 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 PNZ device
- #1 K253612 Acclarent AERA Eustachian Tube Balloon…score 17.5 · 23 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 |
|---|---|---|---|
| * | K163509 | XprESS ENT Dilation SystemSummary page 4…Ear, nose and throat manual surgical instrument Product Code: LRC 3. Predicate Device Information • Primary predicate: XprESS ENT Dilation System (K163509) • Secondary predicate: VenSure and VenSure Nav Balloon Devices (K201472) with VenSure LightGuide (K212774) === Pag… | 2017 |
| * | K201472 | VenSure Balloon Device, VenSure Nav Balloon DeviceSummary page 4…LRC 3. Predicate Device Information • Primary predicate: XprESS ENT Dilation System (K163509) • Secondary predicate: VenSure and VenSure Nav Balloon Devices (K201472) with VenSure LightGuide (K212774) The primary predicate is the predicate device for the added Eust… | 2020 |
| * | K212774 | VenSure LightGuideSummary page 4…Primary predicate: XprESS ENT Dilation System (K163509) • Secondary predicate: VenSure and VenSure Nav Balloon Devices (K201472) with VenSure LightGuide (K212774) The primary predicate is the predicate device for the added Eustachian Tube indication with produc… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 117 ancestors have a recall of any class.
- 4 other devices also cite its predicate K163509.
How does its category compare?
All PNZ devicesPNZ Eustachian Tube Balloon Dilation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PNZ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PNZ
251in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNZ
No recall names PNZ since 2007.
Adverse event reports per year · PNZ
3in 2025
MAUDE reports naming product code PNZ, 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 251 | 0 | 4 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The VenSure™ Balloon Dilation System is used to access and treat the frontal ostia/recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in adult patients using a transnasal…
Read the full statement (148 words)
The VenSure™ Balloon Dilation System is used to access and treat the frontal ostia/recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in adult patients using a transnasal approach.
The VenSure™ Nav Balloon Dilation System is additionally intended for use in conjunction with the Cube Navigation System during ENT procedures when surgical navigation or image-guided surgery may be necessary to locate the Eustachian tube or to locate tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.
The VenSure™ Light Balloon Dilation System is additionally used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230065: VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230065
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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