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Gore Laparoscopic Suture Passer

by W. L. Gore & Associates, Inc.

510(k) K935986

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK935986 Date12 May 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Gore Laparoscopic Suture Passer is a medical device designed for use in laparoscopic procedures to facilitate the passage of sutures. It is intended to assist surgeons in performing minimally invasive surgical techniques by enabling the accurate placement of sutures within the body cavity.

This device is supplied as a single-use or reusable product, depending on the specific model configuration. It is available in various sizes to accommodate different surgical requirements. The Gore Laparoscopic Suture Passer has received FDA 510(k) clearance with the product code GCJ, indicating it is substantially equivalent to predicate devices in this category.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Gore Laparoscopic Suture Passer used for?

    The Gore Laparoscopic Suture Passer is designed for use in laparoscopic procedures to facilitate the passage of sutures. It assists surgeons in performing minimally invasive surgical techniques by enabling accurate placement of sutures within the body cavity.

  • Is the Gore Laparoscopic Suture Passer single-use or reusable?

    The device is supplied as either a single-use or reusable product, depending on the specific model configuration selected to meet different surgical requirements.

  • What sizes and models are available for the Gore Laparoscopic Suture Passer?

    The Gore Laparoscopic Suture Passer is available in various sizes to accommodate different surgical requirements, though specific dimensions are not detailed in the provided information.

  • What regulatory approval has the Gore Laparoscopic Suture Passer received?

    The device has received FDA 510(k) clearance with product code GCJ, indicating it is substantially equivalent to predicate devices in this category. It was cleared on May 12, 1994.