← Back to catalogue

Parietene Duo and Quadra Polypropylene Meshes

FDA 510(k)

Class III (US FDA 510(k))

510(k) K072951

by Sofradim Production

Identifiers

510(k) Number
K072951 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 Parietene Duo and Quadra Polypropylene Meshes are synthetic, urogynecologic surgical meshes designed for transvaginal placement. According to the FDA classification, these devices are intended for pelvic organ prolapse repair, providing tissue reinforcement and long-lasting stabilization of pelvic floor fascial structures.

These meshes are supplied sterile and intended for single-use in surgical settings. They are classified as Class III devices under FDA regulations (884.5980) and were cleared via a 510(k) submission (K072951) with a Special review designation. The product codes OTP confirm their classification as obstetrics/gynecology transvaginal mesh implants, with no noted MRI safety restrictions in the available data.

Frequently asked questions

What are the Parietene Duo and Quadra Polypropylene Meshes primarily used for in surgical settings?

These meshes are designed specifically for transvaginal pelvic organ prolapse repair. They provide tissue reinforcement and long-lasting stabilization of pelvic floor fascial structures, helping to support organs that have descended due to weakened pelvic anatomy.

Are the Parietene Duo and Quadra Polypropylene Meshes intended for reuse, or are they single-use only?

The Parietene Duo and Quadra Polypropylene Meshes are explicitly labeled for single-use in surgical settings. This ensures sterility and safety for each patient, as they are supplied sterile and not intended to be reused.

What types of storage conditions should be followed for these meshes before use?

While the exact storage instructions aren’t detailed here, the meshes are supplied sterile, so they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures to maintain sterility and integrity until use.

Are there any known MRI safety restrictions for the Parietene Duo and Quadra Polypropylene Meshes?

Based on the available data, there are no noted MRI safety restrictions for these meshes. However, clinicians should always verify this with the manufacturer or consult the latest product documentation, as MRI safety can depend on specific clinical scenarios.

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. Sources consulted: Parietene Duo and Quadra Polypropylene Meshes, K072951 - PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES FDA 510 (k ..., Parietene Duo and Quadra Polypropylene Meshes, PDF K072951 - Parietene Duo and Quadra Polypropylene Meshes, Sofradim Production - DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sofradim Production

Sources (1)

  • FDA 510(k) K072951 24 fields · synced Sep 18, 2026