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FDA 510(k)

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization

K-Number: K220057 · 2022-10-07

ApplicantShinva Ande Healthcare Apparatus Co., Ltd.
Decision Date2022-10-07
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is a medical device manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under approval number K220057. 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 Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K220057.

When was Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization approved by the FDA?

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization received FDA 510(k) clearance on 2022-10-07, under approval number K220057.

What company makes Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd..

What is the FDA product code for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

The FDA product code for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is MEG.

Related Clinical Trials

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 NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT02119611 Deep Brain Stimulation Therapy in Movement Disorders RECRUITING NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT06253494 Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer 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 Shinva Ande Healthcare Apparatus Co., Ltd.

K162601Infusion Set for Single Use K193657Disposable Enteral Feeding Syringe with Enfit Connector K202060Disposable IV catheter K201460Closed System Transfer Device K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

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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