510(k) · Cleared
ClearedVirtuoSaph Plus Endoscopic Vessel Harvesting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 21, 2016 as substantially equivalent to K140008 (Terumo Cardiovascular Systems Corporation, 2014) after an 84-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Apr 21, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945975 (1994). 15 ancestors in all, the oldest K904993 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 5 generations backK020143 Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 2002 · Recalled
- 4 generations backK022718 Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Guidant Corporation, Cardiac Surgery · 2002
- 3 generations backK041981 Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant…Guidant Corporation · 2004 · Recalled
- 2 generations backK092789 Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp. · 2010 · Recalled
- 1 generation backK140008 Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation · 2014 · Recalled
- This deviceK160206 VirtuoSaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −5 | K020143 | Vasoview 5 Harvesting Cannula | Guidant Corporation, Cardiac Surgery | 2002 | 1 |
| −4 | K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | 2002 | — |
| −3 | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6… | Guidant Corporation | 2004 | 2 |
| −2 | K092789 | Virtuosaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corp. | 2010 | 2 |
| −1 | K140008 | Virtuosaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corporation | 2014 | 1 |
| 0 (this device) | K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2009 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K140008 | Virtuosaph Plus Endoscopic Vessel Harvesting SystemSummary page 4…e following device as a predicate article for this application: • Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System - Cleared by FDA under K140008 on October 31,2014 Pwpose of Submission: Terumo Cardiovascular Systems Corporation is submitting this Traditional 51 O(k)… | 2014 |
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 22 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 6 of the 15 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary miery bypass grafting and peripheral atiery bypass grafting or radial artery for use in coronary artery bypass grafting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160206: VirtuoSaph Plus Endoscopic Vessel Harvesting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160206
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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