K181097 is an FDA 510(k) clearance for the Cook Cystostomy Catheter 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 January 18, 2019, 267 days after receiving the submission on April 26, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K181097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 26, 2018 |
| Decision Date | January 18, 2019 |
| Days to Decision | 267 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 |