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510(k) K073647

MINITAPE EXTRA URETHRAL SLING by Mpathy Medical Devices, Ltd. — Product Code OTN

K073647 is an FDA 510(k) premarket notification submitted by Mpathy Medical Devices, Ltd. for the device "MINITAPE EXTRA URETHRAL SLING". The FDA issued a decision of Substantially Equivalent on March 3, 2008. The device falls under product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator), a Class II device regulated under 21 CFR 878.3300. Mpathy Medical Devices, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2008
Date Received
December 26, 2007
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 Mpathy Medical Devices, Ltd.

  • K092203 — OMNISURE URETHRAL SLING, MODEL OTK52 (August 12, 2009)
  • K092207 — RESTORELLE POLYPROPYLENE MESH (August 4, 2009)
  • K091180 — MINITAPE URETHRAL SLING (July 14, 2009)
  • K073646 — MINITAPE URETHRAL SLING (February 25, 2008)
  • K053361 — MODIFICATION TO: MINIMESH POLYPROPYLENE MESH (February 6, 2006)
  • K041632 — MINIMESH POLYPROPYLENE MESH (November 17, 2004)

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)
  • K222468 — ArcTO Transobturator Sling System (September 15, 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)

FDA data resources