Virtue Male Sling System with Alexis Wound Retractor Convenience Kit— 510(k) K231891
UnknownColoplast
FDA 510(k) clearance K231891 for Virtue Male Sling System with Alexis Wound Retractor Convenience Kit, Unknown on 2023-09-25. Applicant: Coloplast.
Clearance details
- Applicant
- Coloplast
- Product code
- Code OTM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code OTM
product code OTM- Injury
- 760
- Total
- 760
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.