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510(k) K062697

SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT by Cook Biotech, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2006
Date Received
September 11, 2006
Clearance Type
Special
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 Cook Biotech, Inc.

  • K133306 — SIS HERNIA GRAFT (July 23, 2014)
  • K133011 — DIAPHRAGMATIC HERNIA GRAFT (June 20, 2014)
  • K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT (October 8, 2013)
  • K111695 — HYBRID GRAFT (April 2, 2012)
  • K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER (June 20, 2011)
  • K090688 — COOK UROLOGICAL GRAFT (July 10, 2009)
  • K082682 — SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG (February 27, 2009)
  • K082058 — DYNAMATRIX (October 2, 2008)
  • K073391 — SURGISIS BIODESIGN TISSUE GRAFT (March 21, 2008)
  • K070405 — MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT (October 17, 2007)

Other clearances for product code FTL

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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)