510(k) · Cleared
ClearedGore Flow Reversal System Model GFRS073
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Dec 13, 2012 as substantially equivalent to K083300 (W. L. Gore & Associates, Inc., 2009) after a 65-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Dec 13, 2012
- Review
- 65 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003992 (2001). 28 ancestors in all, the oldest K990487 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 5 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 4 generations backK042218 Accunet Embolic Protection System, RX Accunet Embolic Protection…Guidant Corp. · 2004
- 3 generations backK052166 Modification to: RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- 2 generations backK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
- 1 generation backK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- This deviceK123156 Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −5 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −4 | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection System | Guidant Corp. | 2004 | — |
| −3 | K052166 | Modification to: RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| −2 | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
| −1 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| 0 (this device) | K123156 | Gore Flow Reversal System Model GFRS073 | W. L. Gore & Associates, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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 NTE? 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 NTE device
- #1 K222694 EmPro EPS (EP4514C-190…score 6.4 · 5 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 |
|---|---|---|---|
| * | K083300 | Gore Flow Reversal SystemSummary page 2…ce. 8. Conclusion The rmodified GORE® Flow Reversal System is substantially equivalent to the predicate GORE® Flow Reversal System (K083300) in terms of design, material composition, intended use and performance attributes. RRGORE and Design are Trad… | 2009 |
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 11 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 28 ancestors have a recall of any class.
- 2 other devices also cite its predicate K083300.
How does its category compare?
All NTE devicesNTE Temporary Carotid Catheter For Embolic Capture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NTE
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NTE
105in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NTE
3in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · NTE
405in 2025
MAUDE reports naming product code NTE, 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 | 1 | — | 0 | 119 |
| 2008 | 3 | 95 | 6 | 368 |
| 2009 | 3 | 86 | 0 | 343 |
| 2010 | 1 | — | 0 | 294 |
| 2011 | 4 | 105 | 1 | 304 |
| 2012 | 3 | 30 | 0 | 261 |
| 2013 | 0 | — | 0 | 258 |
| 2014 | 1 | — | 0 | 199 |
| 2015 | 3 | 105 | 0 | 148 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 0 | — | 0 | 141 |
| 2018 | 1 | — | 0 | 158 |
| 2019 | 1 | — | 0 | 233 |
| 2020 | 1 | — | 0 | 238 |
| 2021 | 1 | — | 1 (1) | 327 |
| 2022 | 1 | — | 0 | 326 |
| 2023 | 2 | — | 3 | 354 |
| 2024 | 0 | — | 0 | 398 |
| 2025 | 0 | — | 0 | 405 |
| 2026 | 0 | — | 2 (2) | — |
What is it indicated for?
The GORE® Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:
* Adequate iliac/femoral access
* Common carotid artery diameters between 6 and 12 mm
* External carotid artery diameters less than 6 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123156: Gore Flow Reversal System Model GFRS073.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123156
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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