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510(k) K211847

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

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

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Other clearances for product code OTM

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  • 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)