Shina Syringe; Shina Safety Syringe
K-Number: K231165 · 2023-10-27
ApplicantShina Med Corporation
Decision Date2023-10-27
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Shina Syringe; Shina Safety Syringe is a medical device manufactured by Shina Med Corporation. It received FDA 510(k) clearance on 2023-10-27 under approval number K231165. 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 Shina Syringe; Shina Safety Syringe?
Shina Syringe; Shina Safety Syringe is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Shina Med Corporation. The 510(k) number is K231165.
When was Shina Syringe; Shina Safety Syringe approved by the FDA?
Shina Syringe; Shina Safety Syringe received FDA 510(k) clearance on 2023-10-27, under approval number K231165.
What company makes Shina Syringe; Shina Safety Syringe?
Shina Syringe; Shina Safety Syringe is manufactured by Shina Med Corporation.
What is the FDA product code for Shina Syringe; Shina Safety Syringe?
The FDA product code for Shina Syringe; Shina Safety Syringe is MEG.
Related Clinical Trials
NCT06411054
The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA
RECRUITING
NCT06918587
A Comparative Evaluation of Pharmacokinetics and Immunogenicity.
COMPLETED
NCT07503873
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
NOT_YET_RECRUITING
Other Devices by Shina Med Corporation
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.