Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sunmed Control Syringes

K-Number: K160190 · 2016-11-10

Decision Date2016-11-10
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sunmed Control Syringes is a medical device manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2016-11-10 under approval number K160190. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sunmed Control Syringes?

Sunmed Control Syringes is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.. The 510(k) number is K160190.

When was Sunmed Control Syringes approved by the FDA?

Sunmed Control Syringes received FDA 510(k) clearance on 2016-11-10, under approval number K160190.

What company makes Sunmed Control Syringes?

Sunmed Control Syringes is manufactured by Sunny Medical Device (Shenzhen) Co., Ltd..

What is the FDA product code for Sunmed Control Syringes?

The FDA product code for Sunmed Control Syringes is DXT.

Related Clinical Trials

Other Devices by Sunny Medical Device (Shenzhen) Co., Ltd.

Related Devices (Code: DXT)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.