Sterile Syringes for Single Use
K-Number: K223678 · 2023-02-09
Decision Date2023-02-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Sterile Syringes for Single Use is a medical device manufactured by Shanghai Kindly Enterprise Development Group Co., Ltd.. It received FDA 510(k) clearance on 2023-02-09 under approval number K223678. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sterile Syringes for Single Use?
Sterile Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2023-02-09. It is manufactured by Shanghai Kindly Enterprise Development Group Co., Ltd.. The 510(k) number is K223678.
When was Sterile Syringes for Single Use approved by the FDA?
Sterile Syringes for Single Use received FDA 510(k) clearance on 2023-02-09, under approval number K223678.
What company makes Sterile Syringes for Single Use?
Sterile Syringes for Single Use is manufactured by Shanghai Kindly Enterprise Development Group Co., Ltd..
What is the FDA product code for Sterile Syringes for Single Use?
The FDA product code for Sterile Syringes for Single Use is FMF.
Related Clinical Trials
NCT06420323
NovoX®Cup as Primary Dressing After Breast Reduction
ACTIVE_NOT_RECRUITING
NCT06741657
A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways
COMPLETED
NCT07247825
Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy.
RECRUITING
NCT07384741
Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients
ACTIVE_NOT_RECRUITING
Related PubMed Literature
Other Devices by Shanghai Kindly Enterprise Development Group Co., Ltd.
Related Devices (Code: FMF)
K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd.
K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company
K162602NovoPen EchoNovo Nordisk, Inc.
K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.
K152879Sure-Fine Insulin SyringesShina Med Corporation
K160629InPenCompanion Medical, 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.