K110518 is an FDA 510(k) clearance for the IBAG, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Future Path Medical, LLC (Naples, US). The FDA issued a Cleared decision on June 24, 2011, 121 days after receiving the submission on February 23, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K110518 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 23, 2011 |
| Decision Date | June 24, 2011 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNX — Collector, Urine, (and Accessories) For Indwelling Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5250 |