K182066 is an FDA 510(k) clearance for the O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set. This device is classified as a Catheter, Suprapubic (and Accessories) (Class II - Special Controls, product code KOB).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 30, 2018, 90 days after receiving the submission on August 1, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K182066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 01, 2018 |
| Decision Date | October 30, 2018 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOB — Catheter, Suprapubic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5090 |