📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Treatment of recto-vaginal fistulas.
Clinical Applications
- Surgical treatment of a recto-vaginal fistula.
- Placement within the fistula tract to support tissue ingrowth and closure.
- Use in colorectal or gynecologic fistula-repair procedures.
Practical Considerations
- The plug is available in sizes intended to accommodate different fistula-tract dimensions; the surgeon selects the size based on the anatomy.
- It is made from porcine small intestinal submucosa, so its use may be inappropriate for patients with relevant porcine-material sensitivity or other contraindications identified by the treating surgeon.
- Successful placement requires appropriate fistula-tract preparation, sizing and fixation using standard surgical technique.
- The device is bioabsorbable and is intended to provide a scaffold for tissue healing rather than remain permanently in the body.
- MRI safety information should be confirmed in the current device labeling or with the manufacturer before MRI examination; this record does not establish an MR safety classification.
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.