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FDA 510(k)

Sterile Auto-Disable Syringes with/without Needle for Single Use

K-Number: K210229 · 2022-02-15

ApplicantZhejiang Kangkang Medical-Devices Co., Ltd.
Decision Date2022-02-15
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-02-15 under approval number K210229. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-02-15. It is manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210229.

When was Sterile Auto-Disable Syringes with/without Needle for Single Use approved by the FDA?

Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance on 2022-02-15, under approval number K210229.

What company makes Sterile Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd..

What is the FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use is MEG.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Zhejiang Kangkang Medical-Devices Co., Ltd.

K210232Sterile Hypodermic Needles for Single Use K210227Sterile syringe for single use with/without needle K213535Sterile Safety Hypodermic Needles for Single Use

Related Devices (Code: MEG)

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleSol-Millennium Medical, Inc. K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable NeedleYangzhou Medline Industry, Co., Ltd. K163162Sterile Hypodermic Safety Syringes for Single UseJiangxi Hongda Medical Equipment Group , Ltd. K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc.

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.

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