K212830 is an FDA 510(k) clearance for the CT3000Pro. This device is classified as a Device, Cystometric, Hydraulic (Class II - Special Controls, product code FEN).
Submitted by Srs Medical (North Billerica, US). The FDA issued a Cleared decision on December 21, 2021, 105 days after receiving the submission on September 7, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K212830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2021 |
| Decision Date | December 21, 2021 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEN - Device, Cystometric, Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |