K231891
- 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.