510(k) K260756

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) by Sentinel Medical Technologies, — Product Code EZL

K260756 is an FDA 510(k) premarket notification submitted by Sentinel Medical Technologies, for the device "TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)". The FDA issued a decision of Substantially Equivalent on September 4, 2026. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Sentinel Medical Technologies, has at least 2 other 510(k) clearances on record.