Atlas FDA

OTM

12 FDA 510(k) clearances · Product code

60 daysmedian time to decision
109 days90th percentile
12clearances measured

FDA profile

Official device name
Mesh, Surgical, For Stress Urinary Incontinence, Male
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Flags
Implant
FDA definition
surgical treatment of male stress urinary incontinence post-prostatectomy
Adverse events (MAUDE)
2021: 213 · 2022: 199 · 2023: 28 · 2024: 43 · 2025: 47 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AdVance™ XP Male Sling System (720163-03) (K242960)Boston Scientific Corporation2024-11-15
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (K231891)Coloplast2023-09-25
AdVance XP Male Sling System (K211847)Boston Scientific Corporation2021-12-20
AdVance XP Male Sling (K182169)Boston Scientific Corporation2018-11-27
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT (K113496)Coloplast A/S2012-02-14
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT (K111881)Coloplast A/S2011-08-17
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 (K101297)Coloplast A/S2010-06-03
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (K091152)Coloplast A/S2009-05-07
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM (K082640)Coloplast Manufacturing Us, LLC2008-10-17
I-STOP TRANS OBTURATOR MALE SLING (K063079)Cl Medical2006-11-07
MALE REMEEX SYSTEM (K062341)Specialities Remeex International, S.L.2006-11-02
AMS MALE TRANSOBTURATOR SLING SYSTEM (K053371)American Medical Systems, Inc.2006-02-03

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Every clearance here is in the API, with alerts when new ones post.