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510(k) K092203

OMNISURE URETHRAL SLING, MODEL OTK52 by Mpathy Medical Devices, Ltd. — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2009
Date Received
July 22, 2009
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.

  • K092207 — RESTORELLE POLYPROPYLENE MESH (August 4, 2009)
  • K091180 — MINITAPE URETHRAL SLING (July 14, 2009)
  • K073647 — MINITAPE EXTRA URETHRAL SLING (March 3, 2008)
  • 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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