FMS VUE Fluid Management and Tissue Debridement System
K-Number: K233675 · 2024-02-26
ApplicantDePuy Mitek, Inc.
Decision Date2024-02-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FMS VUE Fluid Management and Tissue Debridement System is a medical device manufactured by DePuy Mitek, Inc.. It received FDA 510(k) clearance on 2024-02-26 under approval number K233675. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FMS VUE Fluid Management and Tissue Debridement System?
FMS VUE Fluid Management and Tissue Debridement System is a medical device that received FDA 510(k) clearance on 2024-02-26. It is manufactured by DePuy Mitek, Inc.. The 510(k) number is K233675.
When was FMS VUE Fluid Management and Tissue Debridement System approved by the FDA?
FMS VUE Fluid Management and Tissue Debridement System received FDA 510(k) clearance on 2024-02-26, under approval number K233675.
What company makes FMS VUE Fluid Management and Tissue Debridement System?
FMS VUE Fluid Management and Tissue Debridement System is manufactured by DePuy Mitek, Inc..
What is the FDA product code for FMS VUE Fluid Management and Tissue Debridement System?
The FDA product code for FMS VUE Fluid Management and Tissue Debridement System is HRX.
Related Clinical Trials
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT07027826
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
RECRUITING
NCT05701917
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
RECRUITING
NCT03053791
Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait
RECRUITING
NCT05174312
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
COMPLETED
Related PubMed Literature
PMID: 42168293
Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling.
Scientific reports (2026)
PMID: 41336744
From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device.
Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)
PMID: 41271017
Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration.
Biomedical journal (2025)
PMID: 41054198
Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences.
International journal of technology assessment in health care (2025)
Other Devices by DePuy Mitek, Inc.
Related Devices (Code: HRX)
K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation
K161878PORTAGE SystemBaylis Medical Company, Inc.
K162475mi-eye 2, mi-eye 2 monitorTrice Medical
K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc.
K160249ULTRA TelescopesOlympus Winter & Ibe GmbH
K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation
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.