TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)— 510(k) K260756

Name: FDA 510(k) clearance K260756
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Substantially Equivalent

Sentinel 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.

Clearance details

Applicant: Sentinel Medical Technologies,
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2026-03-09
Decision date: 2026-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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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, 2020-01-01 through 2026-04-23. 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.