K171601 is an FDA 510(k) clearance for the Ultraxx Nephrostomy Balloon Catheter. This device is classified as a Catheter, Nephrostomy.
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 23, 2018, 267 days after receiving the submission on June 1, 2017.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K171601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2017 |
| Decision Date | February 23, 2018 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |