K240057 is an FDA 510(k) clearance for the TraumaGuard Intra-abdominal Pressure Sensing System, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Sentinel Medical Technologies, LLC (Jacksonville, US). The FDA issued a Cleared decision on April 17, 2024, 100 days after receiving the submission on January 8, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K240057 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 08, 2024 |
| Decision Date | April 17, 2024 |
| Days to Decision | 100 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 |