K091767 is an FDA 510(k) clearance for the 3 WAY SILICONE FOLEY BALLOON CATHETER, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on October 9, 2009, 114 days after receiving the submission on June 17, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K091767 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 2009 |
| Decision Date | October 09, 2009 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |