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Syringe with Safety Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193526

by Jiangsu Caina Medical Co., Ltd

Identifiers

510(k) Number
K193526 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)

This device is a syringe with safety needle, classified under product code FMF. It combines a standard syringe with an integrated safety mechanism designed to retract and secure the needle after use, reducing the risk of needlestick injuries. The safety feature is activated by a simple knock or thump, ensuring hands-free operation and enhanced user safety during disposal.

The device is supplied as a sterile, single-use item in a blister pack, available in multiple needle sizes with color-coded identification for easy differentiation. Compatible with standard syringes, it is intended for use in general hospital settings. Regulatory clearance under FDA 510(k) K193526 confirms its compliance with safety and performance standards for medical injection 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. Sources consulted: Products | Safety Needle | Jiangsu caina medical co.,ltd, Products | Jiangsu caina medical co.,ltd, K193526 FDA 510 (k) - Syringe with safety needle

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Jiangsu Caina Medical Co., Ltd
FDA Applicant
Jiangsu Caina Medical Co.,Ltd

Sources (1)

  • FDA 510(k) K193526 24 fields · synced Sep 19, 2026