TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)— 510(k) K260756
Substantially EquivalentSentinel Medical Technologies,
FDA 510(k) clearance K260756 for TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221), Substantially Equivalent on 2026-09-04. Applicant: Sentinel Medical Technologies,. Device class: 2.
Summary
Sentinel Medical Technologies' TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) is filed under EZL, balloon retention-type catheters. The device name describes pressure sensing, which the code name doesn't mention, and the record doesn't explain the fit.
Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Sentinel filed from Jacksonville, Florida. The decision came 179 calendar days after FDA received it (March 9 to September 4, 2026).
Clearance details
- Applicant
- Sentinel Medical Technologies,
- Product code
- Product code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code EZL
view allAdverse 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.