Identifiers
- 510(k) Number
- K051503 FDA 510(k)
- FDA Product Code
- OTP FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5980 FDA 510(k)
- Regulation Number
- 884.5980 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The UGYTEX Sual Knit Mesh is a synthetic surgical mesh designed for urogynecologic applications, specifically for the transvaginal repair of pelvic organ prolapse. Classified as a Class III device under FDA regulations, it is intended for use in reconstructive procedures to support weakened pelvic tissues and restore anatomical function.
This mesh is supplied in sterile, single-use packaging and is intended for surgical placement by trained healthcare professionals in a clinical setting. It is regulated under FDA 510(k) clearance (K051503) and falls under the product code OTP, adhering to the requirements outlined in regulation number 884.5980. Storage and handling must comply with sterile surgical protocols to ensure integrity prior to use.
Frequently asked questions
What types of pelvic organ prolapse procedures is the UGYTEX Sual Knit Mesh specifically designed for?
The UGYTEX Sual Knit Mesh is designed exclusively for transvaginal repair of pelvic organ prolapse. It is intended to support weakened pelvic tissues during reconstructive procedures to restore anatomical function, ensuring stability in urogynecologic applications.
Is the UGYTEX Sual Knit Mesh intended for single-use or can it be reused?
The UGYTEX Sual Knit Mesh is supplied in sterile, single-use packaging. This ensures patient safety and compliance with surgical protocols, as reuse could compromise sterility and integrity.
How should the UGYTEX Sual Knit Mesh be stored to maintain its sterility?
The mesh must be stored according to sterile surgical protocols to preserve its integrity before use. Since it is single-use and sterile upon packaging, it should remain unopened and protected from contamination until surgical placement.
What regulatory pathway was followed for FDA clearance of the UGYTEX Sual Knit Mesh?
The UGYTEX Sual Knit Mesh received FDA clearance through a 510(k) submission (K051503) under the Traditional review pathway. It was determined to be Substantially Equivalent to a predicate device and falls under product code OTP, regulated by 21 CFR 884.5980, with review by the Obstetrics/Gynecology (OB) Advisory Committee.
Are there different sizes or models available for the UGYTEX Sual Knit Mesh?
The provided data does not specify exact sizes or model variations of the UGYTEX Sual Knit Mesh. However, as a synthetic surgical mesh for urogynecologic applications, it is likely tailored to common transvaginal repair needs. For precise sizing options, consult the manufacturer’s product catalog or surgical guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051503 | Class III | Active |
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Manufacturer
- Manufacturer
- Sofradim Production
Sources (1)
- FDA 510(k) K051503 24 fields · synced Sep 18, 2026