K183323 is an FDA 510(k) clearance for the UPJ Occlusion Balloon Catheter. This device is classified as a Catheter, Ureteral, Gastro-urology (Class II - Special Controls, product code EYB).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 5, 2019, 248 days after receiving the submission on November 30, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K183323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 30, 2018 |
| Decision Date | August 05, 2019 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EYB — Catheter, Ureteral, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |