Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linea…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131511 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)
This device is a disposable surgical stapler system designed for tissue approximation and ligation. It includes circular staplers, curved cutter staplers, linear staplers, reloads, and hemorrhage control components, intended for use in general and plastic surgery procedures. The system facilitates precise stapling and cutting of tissue while minimizing trauma and bleeding during surgical interventions.
The device is supplied as single-use, non-sterile items requiring terminal sterilisation prior to use. It is classified as Class II under FDA regulations and is intended for use in controlled surgical environments. Multiple model and reference codes are listed, indicating variations in size and configuration for different clinical applications. Authorisations include FDA 510K clearance, MDD, and MDR compliance, ensuring adherence to regulatory standards for surgical stapling devices.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K131511 | Class II | Active |
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Manufacturer
- Manufacturer
- Changzhou Sinolinks Medical Innovation Co., Ltd.
Sources (2)
- FDA 510(k) K131511 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026