Shina Syringe; Shina Safety Syringe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231165 FDA 510(k)
- FDA Product Code
- MEG FDA 510(k)
- Models / Variants
- Shina Syringe FDA 510(k)Shina Safety Syringe FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shina Syringe and Shina Safety Syringe are sterile plastic syringes used to inject medicines into the human body. The device consists of an outer cylinder, a push rod, a gasket, and a luer lock, with the safety variant including a needle. It is designed for single-use administration of injectable therapies.
The device is supplied sterile and is intended for single use. It is manufactured by Shina Med Corporation in Anseong-Si, Republic of Korea, and is authorized under FDA 510(k) with a substantially equivalent decision. The product falls under device class 2, product code MEG, and regulation number 880.5860, with a general hospital advisory committee classification.
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: SHINAMED, SHINAMED, About - Shina, Shina Global Trading Company, Shina Global Trading Company - sgtc-us.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231165 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shina Med Corporation
Sources (1)
- FDA 510(k) K231165 24 fields · synced Sep 27, 2026