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FDA 510(k)

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020

K-Number: K101297 · 2010-06-03

ApplicantColoplast A/S
Decision Date2010-06-03
Product CodeOTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 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 2010-06-03 under 510(k) number K101297. 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 MODEL 50020?

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 is a medical device that received FDA 510(k) clearance on 2010-06-03. The listed applicant is Coloplast A/S. The 510(k) number is K101297.

When did VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 receive FDA 510(k) clearance?

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 received FDA 510(k) clearance on 2010-06-03, under 510(k) number K101297.

Who is the listed applicant for VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020?

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 VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020?

The FDA product code for VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 is OTM.

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Related Devices (Code: OTM)

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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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