K024050 is an FDA 510(k) clearance for the COOK NEPHROSTOMY DILATION BALLOON CATHETER SET. This device is classified as a Catheter, Nephrostomy.
Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on February 27, 2003, 80 days after receiving the submission on December 9, 2002.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K024050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2002 |
| Decision Date | February 27, 2003 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |