TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231856 FDA 510(k)
- FDA Product Code
- QNQ 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 TopFine Low Dead Space Syringe is a Low Dead Space Piston Syringe, designed to minimize residual volume within the barrel and plunger assembly. This feature enhances precision in medication delivery by reducing wasted drug volume, particularly in small-dose applications. The syringe is engineered for accurate fluid measurement and administration, ensuring minimal loss of active pharmaceutical ingredients during use.
These syringes are intended for single-use in general hospital settings and are supplied sterile. The models TS-LDS2334 and TS-LDS2534 are classified as Class II devices under FDA regulations and comply with the Medical Device Directive (MDD). They are not MRI-safe and must be stored in a clean, dry environment as per manufacturer guidelines. Authorized under FDA 510(k) clearance and MDD compliance, these syringes are distributed with strict adherence to regulatory standards.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231856 | Class II | Active |
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Manufacturer
- Manufacturer
- Medexel Co., Ltd.
- FDA Applicant
- Medexel Co.,Ltd
Sources (2)
- FDA 510(k) K231856 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026