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FDA 510(k)

MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

K-Number: K010936 · 2001-05-21

ApplicantW. L. Gore & Associates, Inc.
Decision Date2001-05-21
Product CodeOXD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2001-05-21 under 510(k) number K010936. The device is classified under product code OXD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL?

MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL is a medical device that received FDA 510(k) clearance on 2001-05-21. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K010936.

When did MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL receive FDA 510(k) clearance?

MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL received FDA 510(k) clearance on 2001-05-21, under 510(k) number K010936.

Who is the listed applicant for MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL?

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

What is the FDA product code for MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL?

The FDA product code for MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL is OXD.

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Other records listing W. L. Gore & Associates, Inc. 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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Related Devices (Code: OXD)

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.

K001789SEAMGUARD STAPLE LINE REINFORCEMENT MATERIALW. L. Gore & Associates, Inc.K955364SEAMGUARD STAPLE LINE REINFORCEMENT MATERIALW. L. Gore & Associates, Inc.

Official Source

View on FDA Database →

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

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