Medical Device Manufacturer · US , West Lafayette , IN

Cook Biotech, Inc.

31 submissions · 31 cleared · Since 1998
31
Total
31
Cleared
0
Denied

Cook Biotech, Inc. — FDA 510(k) Submissions

Cook Biotech, Inc. has submitted 31 FDA 510(k) premarket notifications since 1998, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mesh, Surgical, Wound Dressing With Animal-derived Material(s), Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, Dura Substitute, Mesh, Surgical, Polymeric . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
SIS HERNIA GRAFT
K133306 · FTM Mesh, Surgical · General & Plastic Surgery
Jul 2014 268d
DIAPHRAGMATIC HERNIA GRAFT
K133011 · OWV Mesh, Surgical, Collagen,... · General & Plastic Surgery
Jun 2014 268d
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · GXQ Dura Substitute · Neurology
Oct 2013 180d
HYBRID GRAFT
K111695 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Apr 2012 291d
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
K110402 · FTM Mesh, Surgical · General & Plastic Surgery
Jun 2011 129d
COOK UROLOGICAL GRAFT
K090688 · PAG Mesh, Surgical,... · Gastroenterology & Urology
Jul 2009 116d
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
K082682 · FTM Mesh, Surgical · General & Plastic Surgery
Feb 2009 165d
DYNAMATRIX
K082058 · NPL Barrier, Animal Source,... · Dental
Oct 2008 73d
SURGISIS BIODESIGN TISSUE GRAFT
K073391 · FTM Mesh, Surgical · General & Plastic Surgery
Mar 2008 109d
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
K070405 · FTM Mesh, Surgical · General & Plastic Surgery
Oct 2007 247d
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
K070738 · FTM Mesh, Surgical · General & Plastic Surgery
Apr 2007 20d
SURGISIS, SURGISIS ES
K062696 · FTM Mesh, Surgical · General & Plastic Surgery
Oct 2006 32d
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K062697 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Oct 2006 32d
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
K062729 · FTM Mesh, Surgical · General & Plastic Surgery
Oct 2006 27d
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
K062320 · FTM Mesh, Surgical · General & Plastic Surgery
Oct 2006 54d
OASIS WOUND MATRIX
K061711 · KGN Wound Dressing With... · General & Plastic Surgery
Jul 2006 30d
SURGISIS STAPLE LINE REINFORCEMENT II
K051048 · FTM Mesh, Surgical · General & Plastic Surgery
Sep 2005 151d
SIS DERMAL AUGMENTATION STRAND
K050246 · FTM Mesh, Surgical · General & Plastic Surgery
May 2005 106d
SIS FISTULA PLUG
K050337 · FTM Mesh, Surgical · General & Plastic Surgery
Mar 2005 27d
SIS PLASTIC SURGERY MATRIX
K034039 · FTM Mesh, Surgical · General & Plastic Surgery
Feb 2004 51d
DURASIS DURAL SUBSTITUTE
K031850 · GXQ Dura Substitute · Neurology
Sep 2003 84d
SURGISIS NERVE CUFF
K031069 · JXI Cuff, Nerve · Neurology
May 2003 41d
SURGISIS STAPLE LINE REINFORCEMENT
K022044 · OXE Mesh, Surgical, Collagen,... · General & Plastic Surgery
Aug 2002 60d
SURGISIS GUIDED TISSUE REGENERATION MATRIX
K010952 · NPL Barrier, Animal Source,... · Dental
Jun 2002 437d
SS MATRIX
K020732 · KGN Wound Dressing With... · General & Plastic Surgery
May 2002 85d
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