GORE LAPAROSCOPIC SUTURE PASSER— 510(k) K935986

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K935986 for GORE LAPAROSCOPIC SUTURE PASSER, Substantially Equivalent on 1994-05-12. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1993-12-14
Decision date: 1994-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.