K193336 is an FDA 510(k) clearance for the Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse. This device is classified as a Oral Wound Dressing.
Submitted by Synedgen, Inc. (Claremont, US). The FDA issued a Cleared decision on May 27, 2020, 177 days after receiving the submission on December 2, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq..
| 510(k) Number | K193336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2019 |
| Decision Date | May 27, 2020 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OLR - Oral Wound Dressing |
| Device Class | - |
| Definition | Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq. |