# K163050: Advance Medical Designs, Inc. Sterile Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Advance Medical Designs, Inc.
- Decided: Oct 25, 2017 after 358 days
- Product code: MUI (Media, Coupling, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961757 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101952: Konix Ultrasound Gel, Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa (2011) Summary page 4.

## Indications for use
Advance Medical Designs, Inc. Sterile Ultrasound Gel is intended for general us as a sterile transmission media for acoustically coupling a transducer to a human body surface during external diagnostic ultrasound imaging procedures. It is placed on the patient's intact skin prior to initiating an ultrasound examination. It is indicated for prescription use only.

Source page: https://510kreport.com/device/K163050
Methodology: https://510kreport.com/methodology