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Sepramesh IP Bioresorbable Coating/Permanent Mesh

FDA 510(k)

Class II (US FDA 510(k))

510(k) K053066

by Genzyme Corporation

Identifiers

510(k) Number
K053066 FDA 510(k)
FDA Product Code
FTL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sepramesh IP Bioresorbable Coating/Permanent Mesh is a sterile, dual-component surgical mesh intended for the reconstruction of soft tissue deficiencies, such as hernia repair. It is composed of co-knitted polypropylene and polyglycolic acid fibers, featuring a bioresorbable barrier coating made of sodium hyaluronate, carboxymethylcellulose, and polyethylene glycol hydrogel.

The hydrogel coating resorbs within 30 days to provide visceral protection during the healing period. This device is supplied as a sterile product for surgical use. It is regulated under FDA 510(k) clearance.

Frequently asked questions

What is the primary purpose of the Sepramesh IP mesh?

The device is intended for the reconstruction of soft tissue deficiencies, specifically including hernia repair procedures.

How does the bioresorbable coating function?

The mesh features a hydrogel coating composed of sodium hyaluronate, carboxymethylcellulose, and polyethylene glycol. This coating resorbs within 30 days of implantation to provide visceral protection during the initial healing period.

What materials are used to construct this surgical mesh?

The mesh is a dual-component device composed of co-knitted polypropylene and polyglycolic acid fibers.

Is this device supplied as a sterile product?

Yes, the Sepramesh IP Bioresorbable Coating/Permanent Mesh is supplied as a sterile product intended for surgical use.

What is the regulatory status of this device?

This device is regulated under FDA 510(k) clearance, which indicates that it has been found substantially equivalent to a predicate device.

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: Sepramesh Ip Bioresorbable Coating/Permanent Mesh, Sepramesh™ IP Composite, Rectangle, 4" x 8" (10.2 cm x 20.3 cm ... - BD, Sepramesh Ip Bioresorbable Barrier - Permanent Mesh (K040868) — Fda 510 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Genzyme Corporation

Sources (1)

  • FDA 510(k) K053066 24 fields · synced Sep 24, 2026