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ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K250835
Identifiers
- 510(k) Number
- K250835 FDA 510(k)
- FDA Product Code
- GDW FDA 510(k)
- Models / Variants
- ETHICON 4000 60mm Compact Stapler (EC3D60C) FDA 510(k)ETHICON 4000 60mm Standard Stapler (EC3D60S) FDA 510(k)ETHICON 4000 60mm Long Stapler (EC3D60L) FDA 510(k)ETHICON 3D 60mm White Reload (ER60W) FDA 510(k)ETHICON 3D 60mm Blue Reload (ER60B) FDA 510(k)ETHICON 3D 60mm Green Reload (ER60G) FDA 510(k)ETHICON 3D 60mm Black Reload (ER60T) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4750 FDA 510(k)
- Regulation Number
- 878.4750 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more models by Ethicon Endo-Surgery, LLC — Class II — FDA_510K — listed in FDA 510(k) — 7 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250835 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (1)
- FDA 510(k) K250835 24 fields · synced Jun 18, 2026