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510(k) K110420

OPHIRA MINI SLING SYSTEM by Promedon S.A — Product Code PAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2012
Date Received
February 14, 2011
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 Promedon S.A

  • K033691 — SAFYRE VS AND SAFYRE T (December 19, 2003)
  • K020007 — SAFYRE SLING SYSTEM (March 21, 2002)

Other clearances for product code PAH

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  • 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)
  • 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)
  • K091180 — MINITAPE URETHRAL SLING (July 14, 2009)