FDA 510(k)

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

Номер K: K260756 · 2026-09-04

Дата решения2026-09-04

Код продуктаEZL

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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

Официальный источник

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