K211691 is an FDA 510(k) clearance for the Ultrast Gel. This device is classified as a Media, Coupling, Ultrasound (Class II - Special Controls, product code MUI).
Submitted by Ultrast, Inc. (Oceanside, US). The FDA issued a Cleared decision on December 22, 2021, 203 days after receiving the submission on June 2, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K211691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2021 |
| Decision Date | December 22, 2021 |
| Days to Decision | 203 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 |