TraumaGuard Intra-abdominal Pressure Sensing System— 510(k) K240057
Substantially EquivalentSentinel Medical Technologies, LLC
FDA 510(k) clearance K240057 for TraumaGuard Intra-abdominal Pressure Sensing System, Substantially Equivalent on 2024-04-17. Applicant: Sentinel Medical Technologies, LLC.
Clearance details
- Applicant
- Sentinel Medical Technologies, LLC
- Product code
- Code EZL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.