K200017 is an FDA 510(k) clearance for the Eclipse DermaFlex Cannula. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Eclipse Medcorp, LLC (The Colony, US). The FDA issued a Cleared decision on November 5, 2020, 307 days after receiving the submission on January 3, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K200017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2020 |
| Decision Date | November 05, 2020 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |