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. Device class: 2.
Clearance details
- Applicant
- Coloplast
- Product code
- Code OTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code OTM
view allMore clearances from Coloplast
view all- K241028 — Luja female (4 models)
- K230165 — Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
- K223821 — Self-Cath Closed System
- K221401 — Self-Cath and Self-Cath Plus
- K222059 — SpeediCath Flex Set
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.