Negative Pressure Wound Therapy Device (V-Move, V-Grand)— 510(k) K241023

Substantially Equivalent

Med Way, Inc.

FDA 510(k) clearance K241023 for Negative Pressure Wound Therapy Device (V-Move, V-Grand), Substantially Equivalent on 2024-08-19. Applicant: Med Way, Inc.. Device class: 2.

Clearance details

Applicant
Med Way, Inc.
Product code
Code OMP
Device class
Class 2
Regulation
21 CFR 878.4780
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Buford, GA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OMP

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Adverse events under product code OMP

product code OMP
Death
31
Injury
1,707
Malfunction
4,047
Other
1
Total
5,786

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.