K211420 is an FDA 510(k) clearance for the Stasis Gel. This device is classified as a Cord, Retraction.
Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on March 14, 2022, 311 days after receiving the submission on May 7, 2021.
This device falls under the Dental FDA review panel.
| 510(k) Number | K211420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2021 |
| Decision Date | March 14, 2022 |
| Days to Decision | 311 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL - Cord, Retraction |
| Device Class | - |