K190591 is an FDA 510(k) clearance for the Safergel Sterile Ultrasound Gel. This device is classified as a Media, Coupling, Ultrasound (Class II - Special Controls, product code MUI).
Submitted by Safersonic Us, Inc. (Highland Park, US). The FDA issued a Cleared decision on October 4, 2019, 211 days after receiving the submission on March 7, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K190591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2019 |
| Decision Date | October 04, 2019 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | MUI - Media, Coupling, Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |