FDA 510(k)

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

Numéro K : K260756 · 2026-09-04

Date de décision2026-09-04

Code produitEZL

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : EZL)

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Source officielle

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