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510(k) K211847

AdVance XP Male Sling System by Boston Scientific Corporation — Product Code OTM

K211847 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "AdVance XP Male Sling System". The FDA issued a decision of Substantially Equivalent on December 20, 2021. The device falls under product code OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male), a Class II device regulated under 21 CFR 878.3300. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2021
Date Received
June 15, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, For Stress Urinary Incontinence, Male
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

surgical treatment of male stress urinary incontinence post-prostatectomy

Other clearances by Boston Scientific Corporation

  • K262462 — TheraSphere 360™ Y-90 Management Platform (July 24, 2026)
  • K262165 — FARADRIVE™ Steerable Sheath (M004PF21M402) (July 24, 2026)
  • K261488 — OBSIDIO Conformable Embolic (July 24, 2026)
  • K261978 — WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent Syst (July 10, 2026)
  • K260428 — RIVOS™ EUS Access Device (M00553900) (June 17, 2026)
  • K260100 — MOSES Raydar™ (May 18, 2026)
  • K260771 — TruSelect™ 2.6 Microcatheter (May 15, 2026)
  • K251273 — Asurys Fluid Management System (March 27, 2026)
  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K260119 — SpaceOAR Vue System (SV-2101) (February 10, 2026)

Other clearances for product code OTM

  • K242960 — AdVance™ XP Male Sling System (720163-03) (November 15, 2024)
  • K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (September 25, 2023)
  • K182169 — AdVance XP Male Sling (November 27, 2018)
  • K113496 — VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT (February 14, 2012)
  • K111881 — VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT (August 17, 2011)
  • K101297 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 (June 3, 2010)
  • K091152 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (May 7, 2009)
  • K082640 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM (October 17, 2008)
  • K063079 — I-STOP TRANS OBTURATOR MALE SLING (November 7, 2006)
  • K062341 — MALE REMEEX SYSTEM (November 2, 2006)

FDA data resources