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510(k) K101297

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 by Coloplast A/S — Product Code OTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2010
Date Received
May 10, 2010
Clearance Type
Special
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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  • K211847 — AdVance XP Male Sling System (December 20, 2021)
  • 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)
  • 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)