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)

Sterile Syringe With Safety Needle

K-Number: K211753 · 2021-10-14

ApplicantJiangxi Hongda Medical Equipment Group , Ltd.
Decision Date2021-10-14
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Syringe With Safety Needle is a medical device manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-10-14 under approval number K211753. 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 Syringe With Safety Needle?

Sterile Syringe With Safety Needle is a medical device that received FDA 510(k) clearance on 2021-10-14. It is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K211753.

When was Sterile Syringe With Safety Needle approved by the FDA?

Sterile Syringe With Safety Needle received FDA 510(k) clearance on 2021-10-14, under approval number K211753.

What company makes Sterile Syringe With Safety Needle?

Sterile Syringe With Safety Needle is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd..

What is the FDA product code for Sterile Syringe With Safety Needle?

The FDA product code for Sterile Syringe With Safety Needle is MEG.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING

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 Jiangxi Hongda Medical Equipment Group , Ltd.

K163160Sterile Single-use Infusion Set K163162Sterile Hypodermic Safety Syringes for Single Use K163161Sterile Single-use Syringe with Needle K210578Medical Nitrile Examination Gloves (Power free, Blue) K210821Medical PVC Examination Gloves

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.

↑