FDA.reportPublic FDA data

COOK BIOTECH, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18359593002340648COOK BIOTECH, INC.1N2026-01-011425 INNOVATION PLACE West Lafayette IN US 47906

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
172921385045820K992159SURGISIS SLINGPAG1999-09-23
172921240265518K980431SURGISISFTM1998-05-28
172921170730482K905766DRAINAGE TUBE RESTRAINT/WOUND COVERGBX1991-03-06
172921238247226K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)KHJ2024-05-24
172921062489388K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftOXN2019-12-27
172921323656730K170945Biodesign Staple Line ReinforcementOXE2017-04-28
172921969612745K170016Biodesign Fistula PlugFTM2017-06-21
172921430018911K162741AxoGuard Nerve ConnectorJXI2016-10-31
172921100432616K161762DynaMatrix/Dynamatrix PlusNPL2017-01-13
172921337144079K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugFTM2016-05-26
172921147751197K161000Biodesign Otologic Repair GraftKHJ2016-05-11
172921993574533K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftFTM2016-04-29
172921576693027K160136Flowable Wound MatrixKGN2016-09-28
172921127169274K152033Cook ECM PowderKGN2015-08-19
172921037891592K150594Biodesign Otologic Repair GraftKHJ2015-09-16
172921205586415K142887SIS Inguinal Hernia Repair GraftFTM2015-10-01
172921651035484K133306SIS HERNIA GRAFTFTM2014-07-23
172921226177338K133011DIAPHRAGMATIC HERNIA GRAFTOWV2014-06-20
172921741905066K132660NERVE CUFFJXI2014-01-10
172921129027370K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTGXQ2013-10-08
172921570268920K121360BIODESIGN ENT REPAIR GRAFTKHJ2013-02-27
172921961312595K110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERFTM2011-06-20
172921926989766K082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGFTM2009-02-27
172921809601609K082058DYNAMATRIXNPL2008-10-02
172921247079511K070405MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENTFTM2007-10-17
172921288720902K062729SURGISIS RVP RECTO-VAGINAL FISTULA PLUGFTM2006-10-10
172921512638938K062697SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFTFTL2006-10-13
172921033319702K062320SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100FTM2006-10-02
172921816607476K061711OASIS WOUND MATRIXKGN2006-07-19
172922048472942K050337SIS FISTULA PLUGFTM2005-03-09
172921507431394K034039SIS PLASTIC SURGERY MATRIXFTM2004-02-18
172921720864949K031850DURASIS DURAL SUBSTITUTEGXQ2003-09-08
172921281653755K031069SURGISIS NERVE CUFFJXI2003-05-15
172921922111342K020654STRATASIS SLING KITPAG2002-04-09
172921005550189
172921176789651
172921390473586
172921528465418
172921559891102
172921587252874
172921589094837
172921611164900
172921634302741
172921831367554
172921862471932
172922073055058

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FTM132017-06-21
KHJ42024-05-24
JXI32016-10-31
KGN32016-09-28
NPL22017-01-13
GXQ22013-10-08
PAG22002-04-09
OXN12019-12-27
OXE12017-04-28
OWV12014-06-20
FTL12006-10-13
GBX11991-03-06