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K231891

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit

510(k) number
K231891
Device name
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
Applicant
Coloplast MN · US
Product code
OTM — Mesh, Surgical, For Stress Urinary Incontinence, Mal
Decision date
2023-09-25
Date received
2023-06-27
Decision
Unknown
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K231891.pdf

Official FDA record: K231891
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.