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)

Advance Medical Designs, Inc. Sterile Ultrasound Gel

K-Number: K163050 · 2017-10-25

ApplicantAdvance Medical Designs, Inc.
Decision Date2017-10-25
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Advance Medical Designs, Inc. Sterile Ultrasound Gel is a medical device manufactured by Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 2017-10-25 under approval number K163050. 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 Advance Medical Designs, Inc. Sterile Ultrasound Gel?

Advance Medical Designs, Inc. Sterile Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2017-10-25. It is manufactured by Advance Medical Designs, Inc.. The 510(k) number is K163050.

When was Advance Medical Designs, Inc. Sterile Ultrasound Gel approved by the FDA?

Advance Medical Designs, Inc. Sterile Ultrasound Gel received FDA 510(k) clearance on 2017-10-25, under approval number K163050.

What company makes Advance Medical Designs, Inc. Sterile Ultrasound Gel?

Advance Medical Designs, Inc. Sterile Ultrasound Gel is manufactured by Advance Medical Designs, Inc..

What is the FDA product code for Advance Medical Designs, Inc. Sterile Ultrasound Gel?

The FDA product code for Advance Medical Designs, Inc. Sterile Ultrasound Gel is MUI.

Related Clinical Trials

NCT04345003 MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids COMPLETED NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT01900132 Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING NCT07340073 Coordinated Reset Deep Brain Stimulation for Parkinson's Disease NOT_YET_RECRUITING NCT07592403 Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis RECRUITING

Related PubMed Literature

PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) 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) PMID: 41262422 Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project. The Lancet regional health. Europe (2025) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Advance Medical Designs, Inc.

K223689Disposable Needle Guides and Grids

Related Devices (Code: MUI)

K151070Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical 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. K163023Other-Sonic Transmission 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.

↑