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Wilson-Cook Medical, Inc.

United States·US-MF-000002658

Last updated September 18, 2026

About

Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.

From the manufacturer's own website. Source

Information

Country: United States
Address: 4900, Bethania Station Road, Winston-Salem, United States
Website: www.cookmedical.com
LinkedIn: linkedin.com/company/cookmedical
Facebook: facebook.com/CookMedical
Email: [email protected]
Phone: 01-336-744-0157
PRRC Contact: Benjamin Nickless
EUDAMED SRN: US-MF-000002658
FDA FEI Number: —
DUNS Number: —

Catalogue (258)

Page 2 of 6

Device	Model / Reference	Registries	Class	Status
Captura® Disposable Hot Biopsy Forceps	K171973	FDA 510(k)	Class II	Active
Wilson-Cook Cystotome	K022595	FDA 510(k)	Class II	Active
Wilson Cook Multiple Band Ligator	K944220	FDA 510(k)	Class II	Active
Wilson-Cook Balloon Inflation Device	K936168	FDA 510(k)	Class II	Active
Wilson-Cook Tri-Tome Select Plus	K033203	FDA 510(k)	Class II	Active
SnapLoc Wire Lock	K213483	FDA 510(k)	Class II	Active
Wilson-Cook Esophageal Prosthesis	K896390	FDA 510(k)	Class II	Active
Web 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 Basket	K171969	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord	K243568	FDA 510(k)	Class II	Active
Cook Gi Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K	K111495	FDA 510(k)	Class II	Active
Wilson-Cook Biliary Introducer With Aspiration Biopsy Needle	K961897	FDA 510(k)	Class II	Active
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle	K171596	FDA 510(k)	Class II	Active
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes	K192908	FDA 510(k)	Class II	Active
Soehendra Biliary Dilating Catheter-Sbdc-7	K851960	FDA 510(k)	Class II	Active
Direct Peroral Cholangioscopy Balloon	K101095	FDA 510(k)	Class II	Active
Wilson-Cook Enteral Feeding Tube, Tiger Tube Enteral Feeding Tube	K043203	FDA 510(k)	Class II	Active
Wilson-Cook Esophageal Motility Catheter	K900239	FDA 510(k)	Class II	Active
Wilson-Cook Gianturco-Rosch Z-Stent And Introducer	K941350	FDA 510(k)	Class II	Active
Wilson-Cook Varices Tamponade Balloon Cuff	K902099	FDA 510(k)	Class II	Active
Wilson-Cook Celiac Plexus Neurolysis Needle	K030618	FDA 510(k)	Class II	Active
Wilson-Cook Russell Gastrostomy Kit	K912047	FDA 510(k)	Class II	Active
Carey Capsule	K873996	FDA 510(k)	Class II	Active
Wilson-Cook Usw Cap And Wire Lock	K040137	FDA 510(k)	Class II	Active
Instinct Endoscopic Hemoclip	K132809	FDA 510(k)	Class II	Active
Wilson-Cook Colon Decompression Set	K900035	FDA 510(k)	Class II	Active
Zimmon Biliary Stent Set	K851962	FDA 510(k)	Class II	Active
Wilson-Cook Zilver Biliary Stent	K020788	FDA 510(k)	Class II	Active
Modification To Wilson-Cook Lung Biopsy Needle	K984157	FDA 510(k)	Class II	Active
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord	K192339	FDA 510(k)	Class II	Active
Wilson-Cook Pancreatic Wedge Stent	K990130	FDA 510(k)	Class II	Active
Wilson-Cook Pull Through Peg Kit	K901163	FDA 510(k)	Class II	Active
Hawkin Needle	K851953	FDA 510(k)	Class I	Active
Howell D.A.S.H Extraction Balloon with Multiple Sizing	K173659	FDA 510(k)	Class II	Active
Wilson-Cook Endoscopic Nasal Biliary Drainage Sets	K896323	FDA 510(k)	Class II	Active
Soehendra Lithotripsy Set	K902170	FDA 510(k)	Class II	Active
Captura Disposable Bronchoscope Biopsy Forceps	K163377	FDA 510(k)	Class II	Active
E.r.c.p.-1 Endoscopic Retrograde Cholangio-Cathete	K851964	FDA 510(k)	Class II	Active
Wilson-Cook Esophageal Balloon Prosthesis	K885309	FDA 510(k)	Class II	Active
Wilson-Cook Lung Biopsy Needle	K897050	FDA 510(k)	Class I	Active
Wilson Cook Wire Guide And Protective Guide	K910497	FDA 510(k)	Class II	Active
Vpds-1 Vennes Pancreatic Dilation Set	K851956	FDA 510(k)	Class II	Active
Rotatable Polypectomy Snare Pos-1	K851958	FDA 510(k)	Class II	Active
Echo Tip Ultra Fiducial Needle	K141356	FDA 510(k)	Class II	Active
Esophageal Z-Stent	K920218	FDA 510(k)	Class II	Active
Wilson-Cook Stone Extractor	K851965	FDA 510(k)	Class II	Active
Quantum TTC Biliary Balloon Dilator	K171223	FDA 510(k)	Class II	Active
Enteral Feeding Tube	K874393	FDA 510(k)	Class II	Active
Classic 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 Catheter	K171989	FDA 510(k)	Class II	Active
Zimmon Esophago-Gastric Balloon Tamponade Device	K900623	FDA 510(k)	Class II	Active
Wilson-Cook Biliary And Gastric Aspiration Needle	K895900	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Cook Medical Europe Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (44)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 3, 2026	Z-1812-2026	—	open, classified	Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Dec 18, 2025	Z-1362-2026	—	open, classified	Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Dec 15, 2025	Z-1298-2026	—	open, classified	Nasal feeding tube packaged without the nasal transfer tube component.
Oct 31, 2024	Z-0582-2025	—	open, classified	Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
Aug 29, 2024	Z-0036-2025	—	open, classified	Specific lots of product have been manufactured with nonconforming raw materials.
Nov 3, 2023	Z-0457-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0461-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0463-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0460-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0458-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0462-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0459-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Jun 22, 2023	Z-2253-2023	—	open, classified	Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
Jun 22, 2023	Z-2252-2023	—	open, classified	Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
May 22, 2023	Z-1979-2023	—	open, classified	There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
May 22, 2023	Z-1978-2023	—	open, classified	There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
Feb 4, 2020	Z-1746-2020	—	terminated	Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
Feb 4, 2020	Z-1745-2020	—	terminated	Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
Jul 24, 2019	Z-2541-2019	—	terminated	Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
Jun 14, 2019	Z-2089-2019	—	terminated	Potential for occluded injection needles.
Jan 4, 2019	Z-1132-2019	—	terminated	Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
Dec 18, 2018	Z-0774-2019	—	terminated	The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).
Dec 18, 2018	Z-0775-2019	—	terminated	The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).
Oct 31, 2005	Z-0270-06	—	terminated	Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.
Jun 9, 2005	Z-0941-05	—	terminated	The reorder number listed on the product label is inaccurate.
Jun 9, 2005	Z-0940-05	—	terminated	The reorder number listed on the product label is inaccurate.
Apr 1, 2005	Z-0699-05	—	terminated	The expiration date listed on the product label is greater than the vendor recommended expiration date.
Apr 1, 2005	Z-0698-05	—	terminated	The expiration date listed on the product label is greater than the vendor recommended expiration date.
May 26, 2004	Z-1003-04	—	terminated	The nasal transfer tube may be missing from the package of the affected lot.
Apr 21, 2004	Z-0906-04	—	terminated	The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.
Apr 21, 2004	Z-0908-04	—	terminated	The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
Jan 15, 2004	Z-0536-04	—	terminated	Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
Dec 22, 2003	Z-0347-04	—	terminated	Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm
Dec 17, 2003	Z-0301-04	—	terminated	Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
Oct 8, 2003	Z-0048-04	—	terminated	Product may be packaged with an incorrect instructions for use (IFU) booklet.
Sep 15, 2003	Z-1292-03	—	terminated	The product was labeled 'esophageal', but contained a 'biliary' ballon
Jul 25, 2003	Z-0080-04	—	terminated	The label is missing the Rx Only symbol.
Jan 30, 2003	Z-1410-04	—	terminated	Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
Aug 28, 2002	Z-0068-04	—	terminated	The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
Aug 21, 2002	Z-0089-04	—	terminated	Complaints were reported of difficulty in stent deployment.
Apr 23, 2002	Z-0079-04	—	terminated	There is a possibility that the affected devices would not capture a biopsy during a procedure.
Jan 8, 2002	Z-1180-03	—	terminated	The inner catheter of the introducer system may break after stent deployment.
Jan 8, 2002	Z-1179-03	—	terminated	The inner catheter of the introducer system may break after stent deployment.
Jan 8, 2002	Z-1181-03	—	terminated	The inner catheter of the introducer system may break after stent deployment.