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FDA 510(k)

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

K-Number: K111881 · 2011-08-17

ApplicantColoplast A/S
Decision Date2011-08-17
Product CodeOTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2011-08-17 under 510(k) number K111881. The device is classified under product code OTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT?

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT is a medical device that received FDA 510(k) clearance on 2011-08-17. The listed applicant is Coloplast A/S. The 510(k) number is K111881.

When did VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT receive FDA 510(k) clearance?

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT received FDA 510(k) clearance on 2011-08-17, under 510(k) number K111881.

Who is the listed applicant for VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT?

The FDA product code for VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT is OTM.

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Related Devices (Code: OTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific CorporationK231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplastK211847AdVance XP Male Sling SystemBoston Scientific CorporationK182169AdVance XP Male SlingBoston Scientific CorporationK113496VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KITColoplast A/SK101297VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020Coloplast A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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