K163050 is an FDA 510(k) clearance for the Advance Medical Designs, Inc. Sterile Ultrasound Gel. This device is classified as a Media, Coupling, Ultrasound (Class II - Special Controls, product code MUI).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on October 25, 2017, 358 days after receiving the submission on November 1, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K163050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2016 |
| Decision Date | October 25, 2017 |
| Days to Decision | 358 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUI — Media, Coupling, Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |