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510(k) K073647

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

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)

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