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ETHICON™ 4000 45mm Compact Stapler (EC3DT45C) +6 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K252739
Identifiers
- 510(k) Number
- K252739 FDA 510(k)
- FDA Product Code
- GDW FDA 510(k)
- Models / Variants
- ETHICON™ 4000 45mm Long Stapler (EC3DT45L) FDA 510(k)ETHICON™ 3D 45mm White Reload (ER45W) FDA 510(k)ETHICON™ 3D 45mm Blue Reload (ER45B) FDA 510(k)ETHICON™ 3D 45mm Green Reload (ER45G) FDA 510(k)ETHICON™ 3D 45mm Black Reload (ER45T) 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 45mm Compact Stapler (EC3DT45C) +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 | K252739 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (1)
- FDA 510(k) K252739 24 fields · synced Jun 18, 2026