ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more— 510(k) K241629
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K241629 for ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more, Substantially Equivalent on 2024-07-03. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.
Clearance details
- Device name as filed
- 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)
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Code GAG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Guaynabo, PR
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More clearances from Ethicon Endo-Surgery, LLC
view allAdverse 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.