VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT— 510(k) K113496

Name: FDA 510(k) clearance K113496
Creator: U.S. Food and Drug Administration
Published: 2012-02-14

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K113496 for VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT, Substantially Equivalent on 2012-02-14. Applicant: Coloplast A/S. Device class: 2.

Clearance details

Applicant: Coloplast A/S
Product code: Code OTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2011-11-25
Decision date: 2012-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OTM

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K242960 — AdVance XP Male Sling System (720163-03)2024-11-15
K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit2023-09-25
K211847 — AdVance XP Male Sling System2021-12-20
K182169 — AdVance XP Male Sling2018-11-27
K111881 — VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT2011-08-17

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Adverse events under product code OTM

product code OTM

Injury: 760
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.