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FDA 510(k)

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM

K-Number: K082640 · 2008-10-17

ApplicantColoplast Manufacturing Us, LLC
Decision Date2008-10-17
Product CodeOTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Manufacturing Us, LLC. It received FDA 510(k) clearance on 2008-10-17 under 510(k) number K082640. 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 VENTRAL URETHRAL ELEVATION SLING SYSTEM?

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Coloplast Manufacturing Us, LLC. The 510(k) number is K082640.

When did VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM receive FDA 510(k) clearance?

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM received FDA 510(k) clearance on 2008-10-17, under 510(k) number K082640.

Who is the listed applicant for VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM?

The FDA 510(k) record lists Coloplast Manufacturing Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM?

The FDA product code for VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM is OTM.

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Other records listing Coloplast Manufacturing Us, LLC as applicant

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K100878SELF CATH CATHETERK093112DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGEK070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

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/SK111881VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KITColoplast 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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