FDA 510(k)

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

N.º K: K260756 · 2026-09-04

SolicitanteSentinel Medical Technologies,

Fecha de decisión2026-09-04

Código de productoEZL

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: EZL)

K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLC K232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.