EasyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210909 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 EasyEndo Lite Linear Cutting Stapler and Loading Unit is a linear cutting stapler designed for transection, resection, and anastomosis creation. It is classified as an implantable staple device and is intended for use in open or minimally invasive surgical procedures across general abdominal, gynecologic, thoracic, and pediatric specialties.
This device is supplied as a single-use, sterile system and is intended for use in controlled surgical environments. It is non-magnetic and compatible with MRI settings, though its use must adhere to standard surgical protocols. The device is authorized under FDA 510(k) clearance and MDR compliance, with a classification as a Class II medical device. Storage and handling must follow manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What surgical specialties can the EasyEndo Lite Linear Cutting Stapler be used in, and how does this differ from other similar devices?
The EasyEndo Lite Linear Cutting Stapler is designed for use in general abdominal, gynecologic, thoracic, and pediatric specialties, as well as open or minimally invasive procedures. This broad applicability distinguishes it from some staplers that may be limited to specific specialties or procedure types. Its versatility makes it suitable for transection, resection, and anastomosis creation across multiple surgical contexts.
Is the EasyEndo Lite Linear Cutting Stapler safe to use in MRI environments, and what precautions should be taken?
Yes, the EasyEndo Lite is non-magnetic and compatible with MRI settings. However, its use must still follow standard surgical protocols to ensure safety. This means adhering to manufacturer guidelines for handling and positioning the device during MRI procedures, as well as consulting MRI-specific safety protocols to avoid any unintended risks.
How is the EasyEndo Lite Linear Cutting Stapler supplied, and what does this mean for its use in a clinical setting?
The EasyEndo Lite is supplied as a single-use, sterile system, meaning each unit is intended for one surgical procedure only. This design ensures sterility and reduces the risk of cross-contamination between patients. Clinicians must follow manufacturer storage and handling instructions to maintain its sterility and functionality before use.
What regulatory pathways has the EasyEndo Lite Linear Cutting Stapler followed, and what does this indicate about its compliance?
The device has undergone FDA 510(k) clearance and MDR compliance, confirming its classification as a Class II medical device. These pathways ensure it meets stringent regulatory standards for safety, effectiveness, and manufacturing quality before market authorization. The clearance type is 'Traditional,' indicating a thorough review process by the FDA.
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. Sources consulted: Disposable Linear Cutter Stapler | Ezisurg Medical, easyEndo™ E-Lite Powered Endoscopic Staplers | Ezisurg Medical, easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use ..., Linear surgical stapler - easyEndo™ Lite - EziSurg Medical ...
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 | K210909 | Class II | Active |
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Manufacturer
- Manufacturer
- Ezisurg Medical Co., Ltd.
Sources (2)
- FDA 510(k) K210909 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026