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ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K241629
Identifiers
- 510(k) Number
- K241629 FDA 510(k)
- FDA Product Code
- GAG FDA 510(k)
- Models / Variants
- ECHELON 3000 45mm Compact Stapler (ECH45C) FDA 510(k)Echelon 3000 45mm Standard Stapler (ECH45S) FDA 510(k)Echelon 3000 45mm Long Stapler (ECH45L) FDA 510(k)Echelon 3000 60mm Compact Stapler (ECH60C) FDA 510(k)Echelon 3000 60mm Standard Stapler (ECH60S) FDA 510(k)Echelon 3000 60mm Long Stapler (ECH60L) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4740 FDA 510(k)
- Regulation Number
- 878.4740 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more models by Ethicon Endo-Surgery, LLC — Class II — FDA_510K — listed in FDA 510(k) — 6 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 | K241629 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (1)
- FDA 510(k) K241629 24 fields · synced Jun 19, 2026