K183035 is an FDA 510(k) clearance for the Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle. This device is classified as a Catheter, Nephrostomy.
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 17, 2019, 197 days after receiving the submission on November 1, 2018.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K183035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 01, 2018 |
| Decision Date | May 17, 2019 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |