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FDA 510(k)

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit

K-Number: K231891 · 2023-09-25

ApplicantColoplast
Decision Date2023-09-25
Product CodeOTM
Advisory CommitteeSU
DecisionUnknown

Device Summary

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit is a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2023-09-25 under approval number K231891. The device is classified under product code OTM. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Virtue Male Sling System with Alexis Wound Retractor Convenience Kit?

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit is a medical device that received FDA 510(k) clearance on 2023-09-25. It is manufactured by Coloplast. The 510(k) number is K231891.

When was Virtue Male Sling System with Alexis Wound Retractor Convenience Kit approved by the FDA?

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit received FDA 510(k) clearance on 2023-09-25, under approval number K231891.

What company makes Virtue Male Sling System with Alexis Wound Retractor Convenience Kit?

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit is manufactured by Coloplast.

What is the FDA product code for Virtue Male Sling System with Alexis Wound Retractor Convenience Kit?

The FDA product code for Virtue Male Sling System with Alexis Wound Retractor Convenience Kit is OTM.

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Official Source

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