FDA.report

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

Related Records

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)DeviceApplicantDecision date
K242960AdVanceĀ™ 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