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FDA 510(k)

GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

K-Number: K053202 · 2005-12-07

ApplicantW.L. Gore & Associates
Decision Date2005-12-07
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is W.L. Gore & Associates. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K053202. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL?

GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is W.L. Gore & Associates. The 510(k) number is K053202.

When did GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL receive FDA 510(k) clearance?

GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL received FDA 510(k) clearance on 2005-12-07, under 510(k) number K053202.

Who is the listed applicant for GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL?

The FDA 510(k) record lists W.L. Gore & Associates as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL?

The FDA product code for GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL is FTL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing W.L. Gore & Associates as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120480GORE(R) EMBOLIC FILTERK093934GORE HYBRID VASCULAR GRAFT

Related Devices (Code: FTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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