Echelon Circular Powered Stapler
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163523 FDA 510(k)
- FDA Product Code
- GDW 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)
The Echelon Circular Powered Stapler is a powered surgical stapling device designed for circular anastomosis, facilitating the joining of tubular structures such as intestines or blood vessels during minimally invasive and open surgical procedures. It employs a circular staple cartridge to apply precise, uniform compression and stapling, ensuring secure tissue approximation while minimizing trauma.
This device is intended for single-use in sterile surgical settings and is classified as a Class II medical device under FDA regulations. It is supplied sterile, packaged for surgical use, and must be handled according to manufacturer guidelines to maintain sterility. The device is MRI-unsafe due to its powered components and is available in various sizes to accommodate different anatomical requirements, as indicated by the associated registration numbers.
Frequently asked questions
What types of surgical procedures is the Echelon Circular Powered Stapler designed to assist with?
The Echelon Circular Powered Stapler is specifically designed for circular anastomosis, which involves joining tubular structures like intestines or blood vessels. It is used in both minimally invasive and open surgical procedures to ensure precise, uniform compression and stapling while minimizing tissue trauma.
Is the Echelon Circular Powered Stapler intended for reuse, or is it meant to be used only once?
The Echelon Circular Powered Stapler is explicitly intended for single-use only in sterile surgical settings. It is supplied sterile and must be handled according to manufacturer guidelines to maintain its sterility, so reuse is not recommended or approved.
How do I know which size of the Echelon Circular Powered Stapler is appropriate for my patient’s anatomy?
The device comes in multiple sizes to accommodate different anatomical requirements, as indicated by the listed registration numbers (e.g., 3011052945, 3006451981). The manufacturer’s documentation or surgical planning should guide size selection based on the specific anatomical structures being joined.
Can the Echelon Circular Powered Stapler be used in an MRI environment, or does it pose any safety risks?
The Echelon Circular Powered Stapler is MRI-unsafe due to its powered components. It should not be used in an MRI environment, as the electromagnetic fields could interfere with the device’s functionality or pose safety risks to the patient.
How should the Echelon Circular Powered Stapler be stored to ensure it remains sterile and functional?
The device must be stored in its original, unopened packaging until ready for use. The manufacturer’s guidelines specify handling procedures to preserve sterility, so avoid exposing the device to moisture, contamination, or physical damage. Always check the packaging for integrity before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K163523 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (2)
- FDA 510(k) K163523 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026