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FDA 510(k)

TraumaGuard Intra-abdominal Pressure Sensing System

K-Number: K210570 · 2021-10-29

ApplicantSentinel Medical Technologies, LLC
Decision Date2021-10-29
Product CodePHU
DecisionSubstantially Equivalent

Device Summary

TraumaGuard Intra-abdominal Pressure Sensing System is a medical device manufactured by Sentinel Medical Technologies, LLC. It received FDA 510(k) clearance on 2021-10-29 under approval number K210570. The device is classified under product code PHU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TraumaGuard Intra-abdominal Pressure Sensing System?

TraumaGuard Intra-abdominal Pressure Sensing System is a medical device that received FDA 510(k) clearance on 2021-10-29. It is manufactured by Sentinel Medical Technologies, LLC. The 510(k) number is K210570.

When was TraumaGuard Intra-abdominal Pressure Sensing System approved by the FDA?

TraumaGuard Intra-abdominal Pressure Sensing System received FDA 510(k) clearance on 2021-10-29, under approval number K210570.

What company makes TraumaGuard Intra-abdominal Pressure Sensing System?

TraumaGuard Intra-abdominal Pressure Sensing System is manufactured by Sentinel Medical Technologies, LLC.

What is the FDA product code for TraumaGuard Intra-abdominal Pressure Sensing System?

The FDA product code for TraumaGuard Intra-abdominal Pressure Sensing System is PHU.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Sentinel Medical Technologies, LLC

K240057TraumaGuard Intra-abdominal Pressure Sensing System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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