K210570 is an FDA 510(k) clearance for the TraumaGuard Intra-abdominal Pressure Sensing System. This device is classified as a Intra-abdominal Pressure Monitoring Device.
Submitted by Sentinel Medical Technologies, LLC (Jacksonville, US). The FDA issued a Cleared decision on October 29, 2021, 245 days after receiving the submission on February 26, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Abdominal Intracompartmental Pressure Monitoring Using Bladder Pressure As A Surrogate For Abdominal Pressure..
| 510(k) Number | K210570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2021 |
| Decision Date | October 29, 2021 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PHU — Intra-abdominal Pressure Monitoring Device |
| Device Class | — |
| Definition | Abdominal Intracompartmental Pressure Monitoring Using Bladder Pressure As A Surrogate For Abdominal Pressure. |