U&U Sterile Piston Syringe Without Needle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132553 FDA 510(k)
- FDA Product Code
- FMF 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)
A sterile piston syringe without needle is a medical device designed for the aspiration, irrigation, or administration of fluids in clinical settings. It consists of a barrel, plunger, and flange, enabling manual control of fluid movement without an attached needle.
This device is supplied sterile and intended for single-use. It is used in general hospital environments for procedures requiring fluid handling where needle attachment is not required or desired. The device has received FDA 510(k) clearance under product code FMF, with K-number K132553, and is manufactured by U&U Medical Technology Co, Ltd.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132553 | Class II | Active |
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Manufacturer
- Manufacturer
- U&U Medical Technology Co, Ltd.
Sources (1)
- FDA 510(k) K132553 24 fields · synced Sep 23, 2026