K140085 is an FDA 510(k) clearance for the UNIVERSA PERCULTANEOUS DRAINAGE CATHETER. This device is classified as a Catheter, Malecot (Class II - Special Controls, product code FEW).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on November 18, 2014, 309 days after receiving the submission on January 13, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K140085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2014 |
| Decision Date | November 18, 2014 |
| Days to Decision | 309 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEW — Catheter, Malecot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5090 |