ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)— 510(k) K241629
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K241629 for ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L), Substantially Equivalent on 2024-07-03. Applicant: Ethicon Endo-Surgery, LLC.
Clearance details
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Code GAG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Guaynabo, PR
Adverse events under product code GAG
product code GAG- Death
- 23
- Injury
- 394
- Malfunction
- 2,304
- Other
- 6
- Total
- 2,727
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.