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510(k) K023898

GYNE IDEAS MINITAPE RP DEVICE by Gyne Ideas , Ltd. — Product Code PAH

K023898 is an FDA 510(k) premarket notification submitted by Gyne Ideas , Ltd. for the device "GYNE IDEAS MINITAPE RP DEVICE". The FDA issued a decision of Substantially Equivalent on June 18, 2003. The device falls under product code PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling), a Class II device regulated under 21 CFR 878.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2003
Date Received
November 22, 2002
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 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)

FDA data resources