Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1037905

FEI Number

1037905

Entity Name

Wilson-Cook Medical Inc.

City/State/Country

Winston Salem, NC, US

Establishment Address

4900 Bethania Station Rd, Winston Salem, NC 27105, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

COOK ENDOSCOPY (Owner Number: 9025083)

Owner / Operator Contact Address

4900 BETHANIA STATION RD. &, 5951 GRASSY CREEK BLVD., Winston Salem, NC 27105, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 ACUSNARE POLYPECTOMY SNARE SOFT GLO-TIP SPRAY CATHETER HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HUIBREGTSE NEEDLE KNIFE PAPILLOTOME FUSION TRIPLE LUMEN NEEDLE KNIFE 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2019-12-02
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2017-07-28
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2018-01-08
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-07-28
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2020-04-30
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-03-07
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-12-11
PID	Esophageal Dilator Balloon With Or Without Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2019-12-02
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2018-04-27
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2001-05-24
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2017-12-20
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-10-28
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-11-13
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-11-24
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2019-03-22
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2020-08-25
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2023-12-06
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2017-07-20
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2023-12-06
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2019-10-28
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-11-13
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-11-13
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-05-18
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2018-06-11
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2014-06-23
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2014-06-23
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2021-08-26
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2017-07-28

Official Correspondent

BRIAN RUCKER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COOK ENDOSCOPY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2025	Wilson-Cook Medical Inc.	2	Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
Z-0001-2016	US Endoscopy Group Inc	2	Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Z-0013-2023	Hobbs Medical, Inc.	2	Hobbs Medical Cytology Brush Catalog Number: 4204
Z-0014-2023	Hobbs Medical, Inc.	2	Hobbs Medical Cytology Brush Catalog Number: 4206
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037905. Last updated year: 2026. Please use registration number 1037905 when referencing this establishment in official correspondence.