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510(k) K231891

Device
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
Applicant
Coloplast
510(k) number
K231891
Product code
OTM
Decision
Unknown (SESK)
Decision date
2023-09-25
Date received
2023-06-27
Regulation
878.3300
Classification name
Mesh, Surgical, For Stress Urinary Incontinence, Male
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Mrkvicka
Address
1601 W. River Rd. N. Plymouth MN US 55411 55411

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OTM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation2024-11-15
K211847AdVance XP Male Sling SystemBoston Scientific Corporation2021-12-20
K182169AdVance XP Male SlingBoston Scientific Corporation2018-11-27
K113496VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KITColoplast A/S2012-02-14
K111881VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KITColoplast A/S2011-08-17
K101297VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020Coloplast A/S2010-06-03
K091152VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020Coloplast A/S2009-05-07
K082640VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEMColoplast Manufacturing Us, LLC2008-10-17
K063079I-STOP TRANS OBTURATOR MALE SLINGCl Medical2006-11-07
K062341MALE REMEEX SYSTEMSpecialities Remeex International, S.L.2006-11-02
K053371AMS MALE TRANSOBTURATOR SLING SYSTEMAmerican Medical Systems, Inc.2006-02-03