K202279 is an FDA 510(k) clearance for the Insignis Subcutaneous Needle Sets. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Innovative Health Sciences, LLC (Chester, US). The FDA issued a Cleared decision on August 13, 2021, 367 days after receiving the submission on August 11, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K202279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2020 |
| Decision Date | August 13, 2021 |
| Days to Decision | 367 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |