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510(k) K980482

TRIANGLE SLING by Influence, Inc. — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1998
Date Received
February 9, 1998
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 Influence, Inc.

  • K981677 — REPOSE BONE SCREW SYSTEM (August 27, 1999)
  • K991792 — CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE (August 12, 1999)
  • K992277 — STAPLETAC BONE ANCHOR SYSTEM (July 30, 1999)
  • K991122 — CRYO-MONO CRYOGRNIC SYSTEM (July 1, 1999)
  • K990160 — MICROTAC-BONE ANCHOR SYSTEM (February 16, 1999)
  • K990095 — STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM (February 1, 1999)
  • K983325 — IN-PROBE II URODYNAMIC SYSTEM (November 24, 1998)
  • K982155 — SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM (August 31, 1998)
  • K981631 — INFLUENCE CLIP SYSTEM (July 28, 1998)
  • K972622 — STRAIGHT-IN BONE SCREW FIXATION SYSTEM (October 9, 1997)

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