K201936 is an FDA 510(k) clearance for the SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Gilero, LLC (Morrisville, US). The FDA issued a Cleared decision on May 6, 2021, 297 days after receiving the submission on July 13, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K201936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2020 |
| Decision Date | May 06, 2021 |
| Days to Decision | 297 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE - Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |