DeviceClearance

FMS VUE Fluid Management and Tissue Debridement System— 510(k) K233675

Substantially Equivalent

DePuy Mitek, Inc.

FDA 510(k) clearance K233675 for FMS VUE Fluid Management and Tissue Debridement System, Substantially Equivalent on 2024-02-26. Applicant: DePuy Mitek, Inc.. Device class: 2.

Clearance details

Applicant
DePuy Mitek, Inc.
Product code
Code HRX
Device class
Class 2
Regulation
21 CFR 888.1100
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raynham, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.