ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS— 510(k) K061156

Substantially Equivalent

Ethicon Endo-Surgery, Inc.

FDA 510(k) clearance K061156 for ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS, Substantially Equivalent on 2006-07-03. Applicant: Ethicon Endo-Surgery, Inc..

Clearance details

Applicant: Ethicon Endo-Surgery, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2006-04-26
Decision date: 2006-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.