Sterile Disposable Syringe with Safety Needle
by Jiangsu Kangbao Medical Equipment Co., Ltd.
510(k) K211329
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211329 | Date15 Nov 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
- 510(k) Number
- FDA Product Code
- MEG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Sterile Disposable Syringe with Safety Needle is a medical device used for injections, designed to provide precise dosage control and low residual volume. It is intended for various injection methods and comes in secure packaging for optimal protection. The device is a type of syringe, classified under the product code MEG and regulation number 880.5860.
The Sterile Disposable Syringe with Safety Needle is supplied sterile and is a single-use device. It is available in various sizes and is designed for use in general hospital settings. The device has been authorized with an FDA 510K clearance, with the decision description stating that it is substantially equivalent. The manufacturer, Jiangsu Kangbao Medical Equipment Co., Ltd., has provided the device with a unique k number, K211329.
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Questions
AI-generated answers, 22 Sep 2026
What is the Sterile Disposable Syringe with Safety Needle used for?
The Sterile Disposable Syringe with Safety Needle is used for injections, providing precise dosage control and low residual volume in various hospital settings.
Is the Sterile Disposable Syringe with Safety Needle supplied sterile?
Yes, the Sterile Disposable Syringe with Safety Needle is supplied sterile and is intended for single-use.
What are the available sizes for the Sterile Disposable Syringe with Safety Needle?
The device is available in various sizes to accommodate different injection needs in general hospital settings.
What is the regulatory status of the Sterile Disposable Syringe with Safety Needle?
The device has been authorized with an FDA 510K clearance, with the decision description stating that it is substantially equivalent.