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surgisis rvp recto-vaginal fistula plug
Cook Biotech
Summary: The Surgisis RVP Recto-Vaginal Fistula Plug is a medical device used to treat recto-vaginal fistulas. It is primarily used by colorectal surgeons and gynecologists.
FDA Clearance Information
Pathway
510K
Number
K062729 ↗
Decision Date
October 10, 2006
Product Code
FTM
Device Class
Class 2
Evidence
0 studies
The Surgisis RVP Recto-Vaginal Fistula Plug was cleared through the FDA 510(k) pathway on October 10, 2006. Manufactured by Cook Biotech, it is classified as a Class II device.
What It Is
The Surgisis RVP Recto-Vaginal Fistula Plug is a bioabsorbable device designed to promote healing of recto-vaginal fistulas. It is made from porcine small intestinal submucosa, which provides a scaffold for tissue regeneration. The plug is inserted into the fistula tract, where it supports tissue in-growth and eventual closure of the fistula.
Clinical Applications
This device is commonly used in surgical procedures to treat recto-vaginal fistulas, which can occur as a complication of childbirth, surgery, or inflammatory bowel disease. It is typically used in colorectal surgery and gynecology settings. Patients who benefit from this device are often women experiencing persistent fistulas that have not responded to conservative management.
Indications for Use
The FDA-cleared indication for this device is the treatment of recto-vaginal fistulas. It is intended for patients who have developed a fistula between the rectum and vagina, often due to trauma or surgical complications.
Practical Considerations
The Surgisis RVP Plug comes in various sizes to accommodate different fistula tract dimensions. It is important to ensure proper sizing and placement for optimal outcomes. The device is compatible with standard surgical techniques used in fistula repair.
Frequently Asked Questions
What is the Surgisis RVP Recto-Vaginal Fistula Plug used for?
It is used to treat recto-vaginal fistulas by promoting tissue regeneration and closure of the fistula tract.
What specialties typically use this device?
Colorectal surgeons and gynecologists typically use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for the treatment of recto-vaginal fistulas, which are abnormal connections between the rectum and vagina.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.