K201789 is an FDA 510(k) clearance for the CT-STOR. This device is classified as a Media, Culture, Ex Vivo, Tissue And Cell (Class II - Special Controls, product code NDS).
Submitted by Energy Delivery Solutions (Jeffersonville, US). The FDA issued a Cleared decision on September 20, 2021, 447 days after receiving the submission on June 30, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K201789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2020 |
| Decision Date | September 20, 2021 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NDS - Media, Culture, Ex Vivo, Tissue And Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5885 |