K211911 is an FDA 510(k) clearance for the Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets. This device is classified as a Catheter, Nephrostomy.
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on March 10, 2022, 262 days after receiving the submission on June 21, 2021.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K211911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 21, 2021 |
| Decision Date | March 10, 2022 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |