510(k) · Cleared
Recalled · 2011Virtuosaph (TM) Endoscopic Vein Harvesting Disposable System, Model MCVS550
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 16, 2009 as substantially equivalent to K031891 (Terumo Cardiovascular Systems Corp., 2003) after a 79-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964171 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 2 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 1 generation backK031891 VirtuosaphTerumo Cardiovascular Systems Corp. · 2003
- This deviceK083194 Virtuosaph (TM) Endoscopic Vein Harvesting Disposable System, Model…Terumo Cardiovascular Systems Corp. · 2009
- Descendant · cites it directly · 2 of its ownK092789 Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK140008 Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK160206 VirtuoSaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation · 2016
Most influential descendants
Showing 3 of 3 · See all- K092789Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp. · 2010 · cites it directly2descendants
- K140008Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation · 2014 · 2 generations on1descendant
- K160206VirtuoSaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −2 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −1 | K031891 | Virtuosaph | Terumo Cardiovascular Systems Corp. | 2003 | — |
| 0 (this device) | K083194 | Virtuosaph (TM) Endoscopic Vein Harvesting Disposable System, Model MCVS550 | Terumo Cardiovascular Systems Corp. | 2009 | — |
| +1 | K092789 | Virtuosaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corp. | 2010 | 2 |
| +2 | K140008 | Virtuosaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corporation | 2014 | 1 |
| +3 | K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 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 |
|---|---|---|---|
| * | K031891 | VirtuosaphSummary page 2…it Predicate Device. VirtuoSaphTM Endoscopic Vein Harvesting Disposable System (K031891) Purpose of the Submission: Modification of the indication for use statement'to'mclude the… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092789 | Virtuosaph Plus Endoscopic Vessel Harvesting System | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 10, 2011 | Not classified | Z-1230-2011 | Other | The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has recieved 46 complaints on the Bipolar cord. The firm investigated and found… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092789 (Terumo Cardiovascular Systems Corp., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
VirtuoSaphTM Endoscopic Vein Harvesting System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting including tissue dissection for use in peripheral and coronary artery bypass grafting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083194: Virtuosaph (TM) Endoscopic Vein Harvesting Disposable System, Model MCVS550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083194
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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