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510(k) K222468

ArcTO Transobturator Sling System by Urocure, LLC — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2022
Date Received
August 16, 2022
Clearance Type
Special
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 Urocure, LLC

  • K222293 — ArcSP Suprapubic Sling System (September 21, 2022)
  • K183134 — ArcTV Transvaginal Sling System (February 7, 2019)

Other clearances for product code OTN

  • K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (June 29, 2023)
  • K222293 — ArcSP Suprapubic Sling System (September 21, 2022)
  • K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, (November 10, 2021)
  • 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)
  • K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS (December 5, 2013)