ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)— 510(k) K081146
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K081146 for ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT), Substantially Equivalent on 2008-06-26. Applicant: Ethicon Endo-Surgery, LLC.
Clearance details
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Code GDW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
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, through . 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.