K140938 is an FDA 510(k) clearance for the OSTOM-I ALERT, a Collector, Ostomy (Class I — General Controls, product code EXB), submitted by 11 Health and Technologies, LLC (Crofton, US). The FDA issued a Cleared decision on October 10, 2014, 182 days after receiving the submission on April 11, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K140938 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2014 |
| Decision Date | October 10, 2014 |
| Days to Decision | 182 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 |