Gore Seamguard Reinforcement

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Ongoing Z-2513-2024 FDA Class II ·initiated 3 Jul 2024

  Devices were labeled with an expiration date of four years and ten days rather than the validated two years.

Trade Name

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce

Generic Name

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Model / Ref / Catalog

CBSG25, CBSG3334, CBSG31, CBSG2829

Primary DI / UDI-DI

00733132655496, 00733132655526, 00733132655519, 00733132655502

Basic UDI-DI

B-00733132655496, B-00733132655526, B-00733132655502, B-00733132655519

510(k) Number

K131658 ↗ 510(k)

K053200 ↗ GUDID

K070644 ↗ GUDID

FDA Product Code

OXC 510(k)

FTL GUDID

EMDN Code

P900201 Polyglycolic acid and associations meshes

GMDN Term

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Device Class

Class III EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Safe

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  CE/MDR MDR 764343 Active Valid to Apr 2028

• GORE® EXCLUDER® Conformable AAA Endoprosthesis

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  CE/MDR MDR 731175 Active Valid to Jul 2031

See all devices from W. L. Gore & Associates, Inc. →

• What types of surgical procedures is the Gore Seamguard Reinforcement intended to support during staple line reinforcement?

  The Gore Seamguard Reinforcement is designed for use in general and plastic surgery procedures where staple line reinforcement is required. It provides additional support to surgical staples during tissue approximation, helping to reduce the risk of dehiscence (sutured wound separation). This makes it suitable for procedures where securing tissue edges with staples is critical to maintaining wound integrity.

• How many sizes or reference codes are available for the Gore Seamguard Reinforcement, and how do I identify the correct one for my procedure?

  The Gore Seamguard Reinforcement is available in multiple sizes, each identified by a unique reference code (e.g., 3003910212, 3027419979). There are over 20 distinct reference codes listed in the regulatory records, so the correct size should be selected based on the specific anatomical requirements and staple line dimensions of your procedure. Consult the manufacturer’s product documentation or a surgical specialist to ensure proper sizing.

• Is the Gore Seamguard Reinforcement intended for single-use only, and if so, how should it be stored to maintain sterility?

  Yes, the Gore Seamguard Reinforcement is supplied in sterile, single-use packaging to ensure patient safety and prevent contamination. To maintain sterility, it must be stored under appropriate conditions as specified by the manufacturer—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the storage instructions provided in the packaging to preserve its integrity before use.

• What regulatory pathways does the Gore Seamguard Reinforcement follow, and how does this affect its availability?

  The Gore Seamguard Reinforcement is authorized through FDA 510(k) clearance (under the Traditional pathway, classified as a Class II device) and complies with the Medical Device Directive (MDD) in Europe. This means it has undergone regulatory review to demonstrate substantial equivalence to predicate devices and meets safety and performance standards. Availability is global, but clinicians should verify local regulatory compliance and distribution channels through the manufacturer or authorized distributors.