FDA.reportPublic FDA data

Wilson-Cook Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10379051037905Wilson-Cook Medical Inc.1N2026-01-014900 Bethania Station Rd Winston Salem NC US 27105

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
163491571111576K972674WILSON-COOK NEEDLE KNIFE PAPILLOTOMEKNS1997-08-15
163491605195628K961897WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLEFCG1997-01-29
163491926624148K960415WILSON-COOK BALLOON INFLATION DEVICEKNT1996-04-26
163491081776278K953951WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTORGCA1995-09-19
163491307577946K941305WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLEFBK1994-06-02
163491327360341K936168WILSON-COOK BALLOON INFLATION DEVICEKNT1994-03-28
163491606780758K923470DISPOSABLE HOT BIOPSY FORCEPSKGE1993-04-21
163491835336202K920703GASTROINTESTINAL FEEDING TUBEKNT1993-12-03
163491974772266K920579LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBEKNT1994-07-08
163491299416646K912047WILSON-COOK RUSSELL GASTROSTOMY KITKNT1991-09-05
163491294049298K901443ZIMMON PAPILLOTOMEKNS1990-06-18
163491929090378K896318WILSON-COOK CYTOLOGY BRUSHESFDX1990-04-09
163491849656271K851962ZIMMON BILIARY STENT SETFGE1985-12-17
163491123755615K851958ROTATABLE POLYPECTOMY SNARE POS-1KNS1985-07-25
163491879160198K851952VARICES INJECTORFBK1985-07-26
163491671033553K251104SureTome™ SW Sphincterotome with DomeTipKNS2025-09-29
163491871530765K213483SnapLoc Wire LockODC2022-04-26
163491470922205K212323Instinct Plus Endoscopic Clipping DevicePKL2021-08-25
163491579945004K200972Hemospray Endoscopic HemostatQAU2020-06-10
163491565501753K200247Fusion Quattro Extraction BalloonGCA2020-02-27
163492019412321K193344Tri-Ex Extraction Balloon with Multiple SizingGCA2019-12-13
163491303215328K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesFDX2019-11-14
163491332567667K191048AcuSnare Polypectomy Snare - DuckbillFDI2019-07-18
163491637617848K190829Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)FBK2019-12-19
163491541304590K182895Wilson-Cook Achalasia BalloonPID2019-01-25
163491833010733K182319Glo-Tip Spray CatheterOCX2019-02-01
163491754841673K173673AcuSnare Polypectomy SnareFDI2018-08-24
163491639920311K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cordsKNS2018-05-24
163491866301721K172288Fusion OMNI SphincterotomeKNS2018-04-17
163491907717443K171993Zimmon Needle Knife PapillotomeKNS2017-08-17
163491039138974K171989Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal CatheterODD2018-03-20
163491676026578K171973Captura® Disposable Hot Biopsy ForcepsKGE2018-03-21
163491781337700K171969Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction BasketLQR2018-03-28
163491411819938K171607Bronchi and Gastrointestinal Cytology BrushFDX2017-07-31
163491053000992K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound NeedleFCG2017-08-04
163491396734060K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterFGE2017-10-13
163491418794283K171223Quantum TTC Biliary Balloon DilatorFGE2017-06-16
163491071621476K163377Captura Disposable Bronchoscope Biopsy ForcepsEOQ2018-02-21
163491484424795K162142Accessory Irrigation AdapterODC2017-04-27
163491101791780K161203Soehendra Stent RetrieverFGE2016-05-04
163491499849744K160170Lehman Manometry CatheterFFX2016-06-20
163491900382082K153763Howell Biliary Aspiration NeedleFCK2017-04-06
163491048165655K141356ECHO TIP ULTRA FIDUCIAL NEEDLENEU2014-06-20
163491753417816K132809INSTINCT ENDOSCOPIC HEMOCLIPPKL2013-10-25
163491248222568K063677FUSION QUATTRO EXTRACTION BALLOON XLGCA2007-01-05
163491861929285K052051OMNI SPHINCTEROTOMEKNS2005-08-05
163491432338418K043203WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBEKNT2005-05-11
163491005899753K040981USW NEEDLEKNIFE PAPILLOTOMEKNS2004-05-07
163491758150629K040800WILOSN-COOK BILIARY DILATION BALLOONFGE2004-06-25
163491953983375K040324WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSHFDX2004-05-20
163491415402530K040129TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZINGGCA2004-02-27
163491900518206K033203WILSON-COOK TRI-TOME SELECT PLUSKNS2003-12-19
163492038456776K020788WILSON-COOK ZILVER BILIARY STENTFGE2002-05-08
163491273138468H150003
163491055146111DEN170015Hemospray Endoscopic HemostatQAU2018-05-07
163491126983915
163491209512817
163491378911668
163491493768365
163491506119100
163491750018576
163491855749561
163491867205103
163491950215775

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNS142025-09-29
GCA82020-02-27
FGE82017-10-13
KNT82005-05-11
FDX52019-11-14
ODC32022-04-26
FBK32019-12-19
FDI32019-07-18
FCG32017-08-04
PKL22021-08-25
QAU22020-06-10
OCX22019-02-01
PID22019-01-25
LQR22018-03-28
KGE22018-03-21
ODD22018-03-20
EOQ22018-02-21
NEU22014-06-20
FCK12017-04-06
FFX12016-06-20

PMN#

129 records. Showing 1-40. Next