K191498 is an FDA 510(k) clearance for the Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc. This device is classified as a Catheter, Nephrostomy.
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on January 29, 2020, 238 days after receiving the submission on June 5, 2019.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K191498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 05, 2019 |
| Decision Date | January 29, 2020 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |