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FDA 510(k)

GORE LAPAROSCOPIC SUTURE PASSER

K-Number: K935986 · 1994-05-12

ApplicantW. L. Gore & Associates, Inc.
Decision Date1994-05-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GORE LAPAROSCOPIC SUTURE PASSER 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 1994-05-12 under 510(k) number K935986. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE LAPAROSCOPIC SUTURE PASSER?

GORE LAPAROSCOPIC SUTURE PASSER is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K935986.

When did GORE LAPAROSCOPIC SUTURE PASSER receive FDA 510(k) clearance?

GORE LAPAROSCOPIC SUTURE PASSER received FDA 510(k) clearance on 1994-05-12, under 510(k) number K935986.

Who is the listed applicant for GORE LAPAROSCOPIC SUTURE PASSER?

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 GORE LAPAROSCOPIC SUTURE PASSER?

The FDA product code for GORE LAPAROSCOPIC SUTURE PASSER is GCJ.

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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: GCJ)

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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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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