# K031891: Virtuosaph

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Jul 29, 2003 after 46 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964171 (1997). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981700: Vasoview Dissection/Vessel Harvesting System, Origin Medsystems, Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K963184: Olympus Subcutaneous Endoscopy System, Olympus America, Inc. (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K083194: Virtuosaph (TM) Endoscopic Vein Harvesting Disposable System, Model MCVS550 (2009), 3 descendants of its own
- K092789: Virtuosaph Plus Endoscopic Vessel Harvesting System (2010), 2 descendants of its own
- K140008: Virtuosaph Plus Endoscopic Vessel Harvesting System (2014), 1 descendant of its own
- K160206: VirtuoSaph Plus Endoscopic Vessel Harvesting System (2016), 0 descendants of its own

## Indications for use
The TCVS ViRuoSaphTM Endoscopic Vein Harvesting Disposable System has application!; in minimally invasive SUQEI-Y allowing access for endoscopic saphenous vein harvesting (commonly known as EVH) including tissue dissection and vessel harvesting along the saphenous vein for us8 in coronary artery bypass grafting.

Source page: https://510kreport.com/device/K031891
Methodology: https://510kreport.com/methodology