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OTM — Mesh, Surgical, For Stress Urinary Incontinence, Male Class II

FDA Device Classification

Classification Details

Product Code
OTM
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
GU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

surgical treatment of male stress urinary incontinence post-prostatectomy

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242960boston scientific corporationAdVance™ XP Male Sling System (720163-03)November 15, 2024
K231891coloplastVirtue Male Sling System with Alexis Wound Retractor Convenience KitSeptember 25, 2023
K211847boston scientific corporationAdVance XP Male Sling SystemDecember 20, 2021
K182169boston scientific corporationAdVance XP Male SlingNovember 27, 2018
K113496coloplastVIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KITFebruary 14, 2012
K111881coloplastVIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KITAugust 17, 2011
K101297coloplastVIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020June 3, 2010
K091152coloplastVIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020May 7, 2009
K082640coloplast manufacturing usVIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEMOctober 17, 2008
K063079cl medicalI-STOP TRANS OBTURATOR MALE SLINGNovember 7, 2006
K062341specialities remeex international, s.lMALE REMEEX SYSTEMNovember 2, 2006
K053371american medical systemsAMS MALE TRANSOBTURATOR SLING SYSTEMFebruary 3, 2006