HSW LAPAROSCOPE AND ACCESSORIES— 510(k) K941967

Substantially Equivalent

Henke-Sass, Wolf GmbH

FDA 510(k) clearance K941967 for HSW LAPAROSCOPE AND ACCESSORIES, Substantially Equivalent on 1994-05-16. Applicant: Henke-Sass, Wolf GmbH.

Clearance details

Applicant: Henke-Sass, Wolf GmbH
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-22
Decision date: 1994-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

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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.