K201248 is an FDA 510(k) clearance for the Syringe Holder accessory. This device is classified as a Vapocoolant Device.
Submitted by Vapocoolshot, Inc. (Jupiter, US). The FDA issued a Cleared decision on August 12, 2020, 93 days after receiving the submission on May 11, 2020.
This device falls under the Physical Medicine FDA review panel.
| 510(k) Number | K201248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2020 |
| Decision Date | August 12, 2020 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | MLY - Vapocoolant Device |
| Device Class | - |