FDA 510(k)

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

Número K: K260756 · 2026-09-04

RequerenteSentinel Medical Technologies,

Data da decisão2026-09-04

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) is the device name listed in this FDA 510(k) record. The listed applicant is Sentinel Medical Technologies,. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K260756. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)?

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Sentinel Medical Technologies,. The 510(k) number is K260756.

When did TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) receive FDA 510(k) clearance?

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) received FDA 510(k) clearance on 2026-09-04, under 510(k) number K260756.

Who is the listed applicant for TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)?

The FDA 510(k) record lists Sentinel Medical Technologies, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)?

The FDA product code for TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) is EZL.

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