Home / 510(k) Clearances / K063079

510(k) K063079

I-STOP TRANS OBTURATOR MALE SLING by Cl Medical — Product Code OTM

K063079 is an FDA 510(k) premarket notification submitted by Cl Medical for the device "I-STOP TRANS OBTURATOR MALE SLING". The FDA issued a decision of Substantially Equivalent on November 7, 2006. The device falls under product code OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male), a Class II device regulated under 21 CFR 878.3300. Cl Medical has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2006
Date Received
October 10, 2006
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 Cl Medical

  • K051533 — I-STOP (August 11, 2005)

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)
  • 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)
  • 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)
  • K062341 — MALE REMEEX SYSTEM (November 2, 2006)

FDA data resources