K181643 is an FDA 510(k) clearance for the SmartBag (SmartPouch), a Collector, Ostomy (Class I — General Controls, product code EXB), submitted by 11 Health Technologies Limited (Borehamwood, GB). The FDA issued a Cleared decision on November 16, 2018, 147 days after receiving the submission on June 22, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K181643 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 22, 2018 |
| Decision Date | November 16, 2018 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXB — Collector, Ostomy |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.5900 |