BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Wilson-Cook Medical Inc.

    Reg #: 1037905 · FEI: 1037905 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    103
    Establishment Types
    2
    Classifications
    25

    Registration Details

    Registration Name
    Wilson-Cook Medical Inc.
    Registration Number
    1037905
    FEI Number
    1037905
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4900 Bethania Station Rd
    City
    Winston Salem
    State
    NC
    ZIP
    27105
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191048

    Owner / Operator

    Firm Name
    COOK ENDOSCOPY
    Operator Number
    9025083
    Address
    4900 BETHANIA STATION RD. &, 5951 GRASSY CREEK BLVD.
    City
    Winston Salem
    State
    NC
    Postal Code
    27105
    Country
    US
    Correspondent
    BRIAN - RUCKER

    Products

    Device Name Product Code
    Snare, Flexible FDI
    Ligator, Esophageal MND
    Endoscopic Cytology Brush FDX
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Tubes, Gastrointestinal (And Accessories) KNT
    Esophageal Dilator Balloon With Or Without Electrode Sensors PID
    Endoscope Channel Accessory ODC
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Biopsy Needle FCG
    Bronchoscope (Flexible Or Rigid) EOQ
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
    Forceps, Biopsy, Electric KGE
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Endoscopic Irrigation/Suction System OCX
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Marker, Radiographic, Implantable NEU
    Hemostatic Metal Clip For The Gi Tract PKL
    Dilator, Esophageal KNQ
    Adaptor, Catheter GCE
    Lithotriptor, Biliary Mechanical LQC
    Dislodger, Stone, Biliary LQR
    Hemostatic Device For Endoscopic Gastrointestinal Use QAU

    Proprietary Names

    ACUSNARE POLYPECTOMY SNARE FOUR SHOOTER SAEED MULTI-BAND LIGATOR SIX SHOOTER SAEED MULTI-BAND LIGATOR TEN SHOOTER SAEED MULTI-BAND LIGATOR BRONCHOSCOPE CYTOLOGY BRUSH CYTOLOGY BRUSH GASTROSCOPE COLONOSCOPE CYTOLOGY BRUSH STANDARD WIRE GUIDE ROADRUNNER WIRE GUIDE DELTA WIRE GUIDE TRACER METRO DIRECT WIRE GUIDE ACROBAT 2 CALIBRATED TIP WIRE GUIDE FUSION WIRE GUIDE LOCKING DEVICE FUSION CYTOLOGY BRUSH CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH DISPOSABLE VARICES INJECTOR ACUJECT VARIABLE INJECTION NEEDLE NASAL JEJUNAL FEEDING TUBE WILSON-COOK ACHALASIA BALLOON ACCESSORY IRRIGATION ADAPTER MEMORY SOFT WIRE BASKET THE WEB EXTRACTION BASKET FUSION LITHOTRIPSY EXTRACTION BASKET MEMORY HARD WIRE BASKET ECHOTIP ULTRA CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE FUSION TRIPLE LUMEN NEEDLE KNIFE SureTome™ SW Sphincterotome with DomeTip FUSION GLO-TIP ERCP CATHETER GLO-TIP II DOUBLE LUMEN ANGLED ERCP CATHETER HUIBREGTSE-KATON ERCP CATHETER GLO-TIP ERCP CATHETER CLASSIC ERCP CATHETER HABER RAMP CATHETER CRAMER ERCP CATHETER GLO-TIP II DOUBLE LUMEN ERCP CATHETER CAPTURA HOT SERRATED FORCEPS W/O SPIKE CAPTURA HOT BIOPSY FORCEPS FUSION QUATTRO EXTRACTION BALLOON CAESAR GRASPING FORCEPS CAPTURA PRO BIOPSY FORCEPS CAPTURA SERRATED FORCEPS W/O SPIKE CAPTURA BIOPSY FORCEPS WITHOUT SPIKE CAPTURA MINI BIOPSY FORCEPS W/O SPIKE ACUSNARE POLYPECTOMY SNARE SOFT GLO-TIP SPRAY CATHETER HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HUIBREGTSE NEEDLE KNIFE PAPILLOTOME FUSION TRIPLE LUMEN SPHINCTEROTOME D.A.S.H. PRE-LOADED WITH ACROBAT 2 WIRE GUIDE UNIVERSAL ACTIVE CORD TRI-TOME PC PROTECTOR CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME HOWELL D.A.S.H. SPHINCTEROTOME COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME COTTON CANNULATOME DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE COTTON CANNULATOME II PC PROTECTOR TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME UTS PRECURVED ULTRA TAPER SPHINCTEROTOME HOWELL D.A.S.H. DIRECT ACCESS SYSTEM D.A.S.H. DOME TIP DOUBLE LUMEN SPHINCTEROTOME COTTON GRADUATED BILIARY DILATION CATHETER FUSION BILIARY DILATION CATHETER SOEHENDRA BILIARY DILATION CATHETER ECHOTIP ULTRA FIDUCIAL NEEDLE Instinct Plus Endoscopic Clipping Device SAVARY GILLIARD DILATOR WASHER SAVARY CLEANING BRUSH QUANTUM TTC COLONIC BALLOON DILATOR QUANTUM TTC ESOPHAGEAL BALLOON DILATOR SAVARY-GILLIARD DILATOR SAVARY-GILLIARD WIRE GUIDE HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL - PYLORIC - COLONIC HERCULES 3 STAGE BALLOON ESOPHAGEAL ECLIPSE TTC WIRE GUIDED BALLOON DILATOR FUSION PRE-LOADED OMNI-TOME FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME FUSION OMNI PRE-LOADED WITH ACROBAT 2 WIRE GUIDE FUSION OMNI-TOME FUSION OMNI PRE-LOADED WITH ACROBAT WIRE GUIDE FUSION OMNI-TOME SPHINCTEROTOME TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING ROTATABLE SIDE ARM ADAPTER SIDE ARM ADAPTER CONQUEST TTC LITHOTRIPTOR CABLE WITH ADAPTER SOEHENDRA LITHOTRIPTOR HANDLE SOEHENDRA LITHOTRIPSY CABLE MEMORY II DOUBLE LUMEN EXTRACTION BASKET WEB II MEMORY EXTRACTION BASKET MEMORY-HELICAL STONE EXTRACTOR BASKET MEMORY EIGHT WIRE BASKET HEMOSPRAY ENDOSCOPIC HEMOSTAT SOEHENDRA STENT RETRIEVER FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING ZIMMON NEEDLE KNIFE PAPILLOTOME SNAPLOC WIRE GUIDE LOCKING DEVICE ESCORT II EXTRACTION BALLOON TRI-EX EXTRACTION BALLOON QUANTUM INFLATION DEVICE DILATION SYRINGE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device