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510(k) K111219

GMD UNIVERSAL URINARY INCONTINENCE SLING by Generic Medical Device, Inc. — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2011
Date Received
May 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

Other clearances by Generic Medical Device, Inc.

  • K083471 — GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 (March 3, 2009)
  • K070018 — UNIVERSAL SURGICAL MESH, MODEL 100 (April 27, 2007)
  • K063429 — GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 (January 17, 2007)

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  • K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (July 21, 2021)
  • K210087 — Athena Surgical RMUS System (April 12, 2021)
  • K201686 — GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ (September 17, 2020)
  • K183134 — ArcTV Transvaginal Sling System (February 7, 2019)
  • K162201 — Desara TV, Desara Blue TV (January 11, 2017)
  • K140843 — DESARA BLUE OV, DESARA BLUE SS (July 1, 2014)