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FDA 510(k)

VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT

K-Number: K113496 · 2012-02-14

ApplicantColoplast A/S
Decision Date2012-02-14
Product CodeOTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE 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 2012-02-14 under 510(k) number K113496. 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 VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT?

VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT is a medical device that received FDA 510(k) clearance on 2012-02-14. The listed applicant is Coloplast A/S. The 510(k) number is K113496.

When did VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT receive FDA 510(k) clearance?

VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT received FDA 510(k) clearance on 2012-02-14, under 510(k) number K113496.

Who is the listed applicant for VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE 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 VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT?

The FDA product code for VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE 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 CorporationK111881VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR 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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