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510(k) K061314

BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH by Davol Inc., Sub. C. R. Bard, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2006
Date Received
May 11, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Davol Inc., Sub. C. R. Bard, Inc.

  • K101851 — VENTRALIGHT ST MESH (July 15, 2010)
  • K092032 — BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117 (December 8, 2009)
  • K081010 — BARD 3DMAX MESH (October 7, 2008)
  • K061754 — BARD COMPOSITE L/P MESH (October 23, 2006)
  • K051848 — SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, (August 11, 2005)
  • K050610 — SALUTE FIXATION SYSTEM (May 25, 2005)
  • K011069 — AQUASENS FLUID MONITORING SYSTEM (August 16, 2001)
  • K003674 — NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORB (December 8, 2000)
  • K991799 — DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO (September 13, 1999)
  • K991637 — BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 (June 22, 1999)

Other clearances for product code FTL

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  • K251955 — Onflex™ Mesh (July 24, 2025)
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  • K250869 — Parietene™ Macroporous Mesh (PPM5050 ) (April 23, 2025)
  • K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (April 9, 2025)
  • K243315 — ProGrip™ Self-Gripping Polypropylene Mesh (January 17, 2025)
  • K241250 — 3DMax Light Mesh (June 14, 2024)
  • K232373 — Progrip™ Self-Gripping Polypropylene Mesh (January 18, 2024)
  • K233402 — Bard 3DMax Mesh (November 1, 2023)
  • K232924 — T-Line® Hernia Mesh (October 18, 2023)