Sterile and Non-Sterile Ultrasound Gels
K-Number: K232957 · 2023-12-15
ApplicantJianerkang Medical Co., Ltd.
Decision Date2023-12-15
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sterile and Non-Sterile Ultrasound Gels is a medical device manufactured by Jianerkang Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-15 under approval number K232957. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sterile and Non-Sterile Ultrasound Gels?
Sterile and Non-Sterile Ultrasound Gels is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Jianerkang Medical Co., Ltd.. The 510(k) number is K232957.
When was Sterile and Non-Sterile Ultrasound Gels approved by the FDA?
Sterile and Non-Sterile Ultrasound Gels received FDA 510(k) clearance on 2023-12-15, under approval number K232957.
What company makes Sterile and Non-Sterile Ultrasound Gels?
Sterile and Non-Sterile Ultrasound Gels is manufactured by Jianerkang Medical Co., Ltd..
What is the FDA product code for Sterile and Non-Sterile Ultrasound Gels?
The FDA product code for Sterile and Non-Sterile Ultrasound Gels is MUI.
Related Clinical Trials
Related Devices (Code: MUI)
K151070Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical
K163050Advance Medical Designs, Inc. Sterile Ultrasound GelAdvance Medical Designs, Inc.
K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc.
K163027Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc.
K163026Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc.
K163024Ultra/Phonic Conductivity GelPharmaceutical Innovations, 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.