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510(k) K022044

SURGISIS STAPLE LINE REINFORCEMENT by Cook Biotech, Inc. — Product Code OXE

K022044 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SURGISIS STAPLE LINE REINFORCEMENT". The FDA issued a decision of Substantially Equivalent on August 23, 2002. The device falls under product code OXE (Mesh, Surgical, Collagen, Staple Line Reinforcement), a Class II device regulated under 21 CFR 878.3300. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2002
Date Received
June 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Staple Line Reinforcement
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.

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 OXE

  • K170945 — Biodesign Staple Line Reinforcement (April 28, 2017)
  • K153364 — Kerecis SecureMesh (August 19, 2016)
  • K030879 — VERITAS COLLAGEN MATRIX (April 24, 2003)

FDA data resources