FDA 510(k)

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use

K-Number: K183665 · 2019-09-06

ApplicantJiangsu Micsafe Medical Technology Co., Ltd.

Decision Date2019-09-06

Product CodeMEG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K183665. 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 Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K183665.

When did Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183665.

Who is the listed applicant for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

The FDA 510(k) record lists Jiangsu Micsafe Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

The FDA product code for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is MEG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06358391To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.RECRUITING NCT07654907Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain ManagementNOT_YET_RECRUITING NCT06741657A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different WaysCOMPLETED NCT07640126Efficacy of Three-Needle Dazhui and Electroacupuncture for Cervical Spondylosis With Wind-Cold SyndromeRECRUITING NCT07783698Cook iMRI Needles NSR Clinical StudyCOMPLETED

Other records listing Jiangsu Micsafe Medical Technology Co., Ltd. as applicant

K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single K202570Insulin Syringe, Insulin Syringe with Safety Retractable K202205Surgical Face Mask K181426Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)

Related Devices (Code: MEG)

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

Official Source

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