ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Staple
Summary
Ethicon Endo-Surgery, LLC received 510(k) clearance for ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T), a GDW device. Cleared on 2024-10-28.
Details
Source
510(k) Clearance
External ID
K241630
Action Date
2024-10-28
Status
Traditional
Category
device
Product Code
GDW
Product Description
ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T). Product code: GDW.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Ethicon Endo-Surgery, LLC has received 12 total clearances in our database.
Ethicon Endo-Surgery, LLC has 16 FDA actions in our database, including 4 recalls and 12 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Ethicon Endo-Surgery, LLC have FDA actions?
Ethicon Endo-Surgery, LLC has 16 FDA actions in our database, including 4 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241630" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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