OTM · Class II · 21 CFR 878.3300

FDA Product Code OTM: Mesh, Surgical, For Stress Urinary Incontinence, Male

Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy

Leading manufacturers include Coloplast A/S, Boston Scientific Corporation and Coloplast Manufacturing Us, LLC.

12
Total
12
Cleared
68d
Avg days
2006
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 51d recently vs 70d historically

FDA 510(k) Cleared Mesh, Surgical, For Stress Urinary Incontinence, Male Devices (Product Code OTM)

12 devices
1–12 of 12
Cleared Nov 15, 2024
AdVance™ XP Male Sling System (720163-03)
K242960
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Sep 25, 2023
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
K231891
Coloplast
Gastroenterology & Urology · 90d
Cleared Dec 20, 2021
AdVance XP Male Sling System
K211847
Boston Scientific Corporation
Gastroenterology & Urology · 188d
Cleared Nov 27, 2018
AdVance XP Male Sling
K182169
Boston Scientific Corporation
Gastroenterology & Urology · 109d
Cleared Feb 14, 2012
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
K113496
Coloplast A/S
Gastroenterology & Urology · 81d
Cleared Aug 17, 2011
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
K111881
Coloplast A/S
General Hospital · 47d
Cleared Jun 03, 2010
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
K101297
Coloplast A/S
Gastroenterology & Urology · 24d
Cleared May 07, 2009
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
K091152
Coloplast A/S
Gastroenterology & Urology · 17d
Cleared Oct 17, 2008
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
K082640
Coloplast Manufacturing Us, LLC
Gastroenterology & Urology · 37d
Cleared Nov 07, 2006
I-STOP TRANS OBTURATOR MALE SLING
K063079
Cl Medical
Gastroenterology & Urology · 28d
Cleared Nov 02, 2006
MALE REMEEX SYSTEM
K062341
Specialities Remeex International, S.L.
Gastroenterology & Urology · 84d
Cleared Feb 03, 2006
AMS MALE TRANSOBTURATOR SLING SYSTEM
K053371
American Medical Systems, Inc.
Gastroenterology & Urology · 60d

About Product Code OTM - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code OTM since 2006, with 12 receiving FDA clearance (average review time: 68 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - OTM Product Code

Recent submissions under OTM have taken an average of 51 days to reach a decision - down from 70 days historically, suggesting improved FDA processing for this classification.

OTM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →