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Symbotex Composite Mesh

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131969

by Sofradim Production

Identifiers

510(k) Number
K131969 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 Symbotex Composite Mesh is a surgical mesh classified as a Mesh, Surgical, Polymeric device. It is designed for soft tissue reinforcement, commonly used in hernia repair procedures to provide structural support and stability to weakened or damaged tissues.

This mesh features a self-gripping mechanism to facilitate positioning and secure placement without requiring additional fixation devices. Supplied in sterile, single-use form, it is intended for use in controlled surgical environments. Authorized under FDA 510(k) clearance (K131969) and regulated under 21 CFR 878.3300, it adheres to standards for General and Plastic Surgery applications.

Frequently asked questions

What types of surgical procedures is the Symbotex Composite Mesh primarily used for?

The Symbotex Composite Mesh is primarily designed for soft tissue reinforcement, particularly in hernia repair procedures. Its self-gripping mechanism helps provide structural support and stability to weakened or damaged tissues, making it suitable for reinforcing areas during surgical interventions where tissue integrity is compromised.

Is the Symbotex Composite Mesh intended for single-use or can it be reused?

The Symbotex Composite Mesh is explicitly supplied in a sterile, single-use form. This ensures patient safety and maintains the integrity of the device for one surgical procedure only, adhering to best practices for surgical implants.

How is the Symbotex Composite Mesh positioned during surgery, and does it require additional fixation devices?

The Symbotex Composite Mesh features a self-gripping mechanism, which allows it to adhere securely to tissues without requiring additional fixation devices. This design simplifies placement and reduces the need for extra surgical tools during hernia repair or similar procedures.

What regulatory pathway was followed for the FDA clearance of the Symbotex Composite Mesh?

The Symbotex Composite Mesh received FDA clearance through a 510(k) submission, specifically under the traditional review pathway (K131969). It was determined to be substantially equivalent to a predicate device and is regulated under 21 CFR 878.3300, falling under the Mesh, Surgical, Polymeric classification for General and Plastic Surgery applications.

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: SYMBOTEX(TM) COMPOSITE MESH (K131969) — FDA 510(k) | Innolitics, Symbotex Composite Mesh - Sofradim Production | FDA Reference, SYMBOTEX (TM) COMPOSITE MESH 510 (k) K131969 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sofradim Production

Sources (1)

  • FDA 510(k) K131969 24 fields · synced Sep 19, 2026