Virtuosaph
by Terumo Cardiovascular Systems Corporation
510(k) K031891
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031891 | Date29 Jul 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GCJ
- FDA applicant
- Terumo Cardiovascular Systems Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The VirtuoSaph Plus Endoscopic Vessel Harvesting System is an endoscopic device designed for minimally invasive harvesting of saphenous veins or radial arteries. It is classified as a vessel harvesting instrument under the product code GCJ and is intended for use in coronary and peripheral artery bypass graft procedures. The system facilitates the extraction of vessels through small incisions, reducing trauma and improving graft quality. Its use aligns with endoscopic techniques to enhance procedural precision and patient outcomes.
This system is supplied as a reusable medical device and is intended for use in sterile surgical environments. It is approved under FDA 510(k) clearance (K031891) as substantially equivalent to prior-generation devices, with advisory review by the Gastroenterology and Urology committees. The device is not labeled for MRI compatibility or single-use applications. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality. No additional regulatory markings beyond the FDA clearance are stated.
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Questions
AI-generated answers, 1 Oct 2026
What is the VirtuoSaph Plus Endoscopic Vessel Harvesting System used for?
The VirtuoSaph Plus is designed specifically for minimally invasive harvesting of saphenous veins or radial arteries during coronary and peripheral artery bypass graft procedures. By using endoscopic techniques, it allows vessels to be extracted through small incisions, which reduces tissue trauma and helps preserve graft quality—critical factors for successful bypass outcomes.
Is the VirtuoSaph Plus a single-use or reusable device?
The VirtuoSaph Plus is supplied as a reusable medical device. It is intended for use in sterile surgical environments, meaning it must undergo proper cleaning, sterilization, and maintenance between procedures to ensure safety and functionality. Reusability aligns with standard surgical instrument protocols.
How does the device’s endoscopic design benefit patients?
The endoscopic approach minimizes incision size compared to traditional open harvesting methods, reducing postoperative pain, scarring, and recovery time. This precision also lowers the risk of vessel damage, which can improve graft patency and long-term success in bypass procedures.
What storage and handling requirements apply to the VirtuoSaph Plus?
The device must be stored and handled according to standard surgical instrument protocols to maintain sterility and functionality. This includes proper cleaning, sterilization (e.g., autoclave or chemical sterilization), and storage in a clean, dry environment away from contaminants. Follow manufacturer guidelines to prevent damage or degradation.
Can the VirtuoSaph Plus be used with MRI imaging?
The device is not labeled for MRI compatibility. If MRI imaging is required for the patient post-procedure, ensure the entire system (including any attached components) is removed from the surgical field beforehand to avoid interference or safety risks.