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510(k) K063136

NEEDLELESS SLING by Specialities Remeex International, S.L. — Product Code PAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2006
Date Received
October 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

Other clearances by Specialities Remeex International, S.L.

  • K062341 — MALE REMEEX SYSTEM (November 2, 2006)
  • K033310 — REMEEX SYSTEM FOR URINARY INCONTINENCE (January 15, 2004)

Other clearances for product code PAH

  • K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (5 (October 18, 2024)
  • K221874 — Altis Single Incision Sling System (February 15, 2023)
  • K191416 — Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sli (February 7, 2020)
  • K121562 — ALTIS SINGLE INCISION CLING SYSTEM (November 5, 2012)
  • K123179 — AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING (November 2, 2012)
  • K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEM (September 7, 2012)
  • K110420 — OPHIRA MINI SLING SYSTEM (May 8, 2012)
  • K103418 — DESARA MINI (November 30, 2011)
  • K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (June 7, 2010)
  • K092607 — AJUST ADJUSTABLE SINGLE INCISION SLING (November 20, 2009)