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Gore Seamguard Bioabsorbable Staple Line Reinforcement Material

FDA 510(k)

Class II (US FDA 510(k))

510(k) K053202

by W.L. Gore & Associates

Identifiers

510(k) Number
K053202 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 Gore Seamguard Bioabsorbable Staple Line Reinforcement Material is a polymeric surgical mesh designed to reinforce suture and staple lines. It functions by distributing staple pressure across a wider surface area, which mechanically increases the strength of the resection line.

This device is indicated for use during surgical procedures, including the occlusion of the left atrial appendage during open chest cardiac surgery. It is a bioabsorbable material that provides a consistent, thin reinforcement to tissue.

Frequently asked questions

What is the primary function of the Gore Seamguard material?

The material acts as a polymeric surgical mesh that reinforces suture and staple lines. It functions by distributing staple pressure across a wider surface area, which mechanically increases the strength of the resection line during surgical procedures.

In what surgical procedures is this device indicated for use?

This device is indicated for use during various surgical procedures, including the occlusion of the left atrial appendage during open chest cardiac surgery, where it provides a consistent, thin reinforcement to the tissue.

Is the Gore Seamguard material permanent or absorbable?

The device is made of a bioabsorbable material. This allows it to provide necessary reinforcement to the tissue during the healing process without remaining as a permanent implant.

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: SEAMGUARD® Bioabsorbable Staple Line Reinforcement - GORE, SEAMGUARD® Bioabsorbable Staple Line Reinforcement - GORE, GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement - EMECLAR, PDF W. L. Gore Associates, Inc. GORE' SEAMGUARD® Reinforcement SUMMAR

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
W.L. Gore & Associates

Sources (1)

  • FDA 510(k) K053202 24 fields · synced Sep 22, 2026