VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT— 510(k) K111881
Substantially EquivalentColoplast A/S
FDA 510(k) clearance K111881 for VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT, Substantially Equivalent on 2011-08-17. Applicant: Coloplast A/S.
Clearance details
- Applicant
- Coloplast A/S
- Product code
- Code OTM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- 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.