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FDA 510(k)

Automatic Continuous Effusion Shunt (ACES) System ACES System

K-Number: K231096 · 2023-08-18

ApplicantPleural Dynamics, Inc.
Decision Date2023-08-18
Product CodeKPM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Automatic Continuous Effusion Shunt (ACES) System ACES System is a medical device manufactured by Pleural Dynamics, Inc.. It received FDA 510(k) clearance on 2023-08-18 under approval number K231096. The device is classified under product code KPM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Automatic Continuous Effusion Shunt (ACES) System ACES System?

Automatic Continuous Effusion Shunt (ACES) System ACES System is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Pleural Dynamics, Inc.. The 510(k) number is K231096.

When was Automatic Continuous Effusion Shunt (ACES) System ACES System approved by the FDA?

Automatic Continuous Effusion Shunt (ACES) System ACES System received FDA 510(k) clearance on 2023-08-18, under approval number K231096.

What company makes Automatic Continuous Effusion Shunt (ACES) System ACES System?

Automatic Continuous Effusion Shunt (ACES) System ACES System is manufactured by Pleural Dynamics, Inc..

What is the FDA product code for Automatic Continuous Effusion Shunt (ACES) System ACES System?

The FDA product code for Automatic Continuous Effusion Shunt (ACES) System ACES System is KPM.

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Related Devices (Code: KPM)

K170405BD Curve Ascites ShuntCare Fusion

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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