ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more— 510(k) K250835
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K250835 for ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more, Substantially Equivalent on 2025-05-14. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.
Clearance details
- Device name as filed
- ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guaynabo, PR, US
Recent devices under product code GDW
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- K221790 — HARMONIC 700 Shears
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.