Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter w…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200420 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 Contour Curved Cutter is a surgical stapling device designed for tissue approximation and division. It uses a curved cutting head to apply staples and make precise incisions in soft tissue, facilitating controlled separation during minimally invasive procedures. The device is part of a reloadable system, allowing for interchangeable reloads to accommodate different surgical needs.
This device is intended for use in operating rooms and surgical settings, typically in general and plastic surgery. It is supplied as a reusable surgical instrument with disposable reloads, which are single-use and intended for one surgical procedure. The reloads are available in blue and green variants, and the device is classified under FDA regulation 878.4750. Authorisations include FDA 510K clearance and MDR compliance.
Frequently asked questions
What surgical specialties is the Echelon Contour Curved Cutter primarily intended for use in, and how does its design support those procedures?
The Echelon Contour Curved Cutter is designed for use in general and plastic surgery, as indicated by its advisory committee classification. Its curved cutting head allows for precise tissue approximation and division, which is particularly useful in minimally invasive procedures where controlled separation of soft tissue is required. The reloadable system also accommodates various surgical needs, enhancing flexibility in these specialties.
Are the reloads for the Echelon Contour Curved Cutter reusable, and if not, how many times can they be used per surgical procedure?
The reloads for the Echelon Contour Curved Cutter are explicitly labeled as single-use and intended for one surgical procedure only. They are disposable components designed to be used once and then discarded, ensuring sterility and safety for each patient.
What color variants of reloads are available for the Echelon Contour Curved Cutter, and does this affect functionality?
The Echelon Contour Curved Cutter reloads are available in blue and green variants, but the color does not impact functionality—it is purely for differentiation. Both variants are designed to work interchangeably with the reusable surgical instrument, allowing surgeons to select based on preference or procedural requirements.
How should the Echelon Contour Curved Cutter and its reloads be stored to maintain sterility and usability?
Since the reloads are single-use and the instrument is reusable, the reloads must be stored in their original, sealed packaging until immediately before use to preserve sterility. The reusable surgical instrument should be cleaned, disinfected, and sterilized according to manufacturer guidelines between procedures to ensure safe reuse.
What regulatory pathways has the Echelon Contour Curved Cutter followed, and what does this mean for its use in clinical settings?
The device has obtained FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and effectiveness. This means it has undergone evaluation by the FDA and EU authorities, respectively, and can be legally marketed and used in clinical settings in the U.S. and EU under the specified regulatory frameworks. The classification under FDA regulation 878.4750 further supports its intended use in surgical stapling procedures.
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 | K200420 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (2)
- FDA 510(k) K200420 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026