Cook Endoscopy
Medical device manufacturer in Winston-Salem, NC.
4510(k) clearances
1PMA approvals
14recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K192697 | Instinct Plus Endoscopic Clipping DevicePKL · Traditional | 03/05/2020SE |
| K090183 | Hercules 3 Stage Wire Guided Dilation BalloonKNQ · Special | 09/25/2009SE |
| K083330 | Echotip Ultra Ultrasound NeedleFCG · Traditional | 02/06/2009SE |
| K061937 | Cook Endoscopy Esophageal Dilation BalloonKNQ · Traditional | 12/01/2006SE |
PMA approvals
- P020021 Wizard X-Cell Photodynamic Therapy Balloon with Fiber Optic Diffuser · 08/01/2003 · 0 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2691-2011 | Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product…The disposable clip may not deploy after being positioned inside the patient. | 06/07/2011Terminated |
| Z-0926-2011 | DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook…There is a risk of gastrointestinal perforation or air embolism due to balloon deflation difficulty… | 12/23/2010Terminated |
| Z-0925-2011 | DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical…Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air… | 12/23/2010Terminated |
| Z-0092-2011 | Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station…A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the… | 09/03/2010Terminated |
| Z-0091-2011 | Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station…A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the… | 09/03/2010Terminated |
| Z-1910-2009 | Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for…The English only version of the Patient Care Manuals that accompany the device were shipped to a medical… | 07/24/2009Terminated |
| Z-1598-2009 | Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station…The wire control port of these devices may be missing due to omission of a manufacturing activity. | 06/12/2009Terminated |
| Z-1059-2009 | AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy…The snare head is hexagonal but the handle and packaging indicate an oval reorder number. | 01/21/2009Terminated |
| Z-0325-2009 | FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900…The wire control port may have been omitted during manufacture. | 10/30/2008Terminated |
| Z-0113-2009 | Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent…A section of the introduction system may detach after the stent has deployed. | 09/11/2008Terminated |
| Z-2332-2008 | Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single…It is possible the stents inside CLSO-10-10, lot W2512492 were 5cm in length, instead of 10cm in length as… | 07/02/2008Terminated |
| Z-2331-2008 | Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm…The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures… | 07/02/2008Terminated |
| Z-0520-2007 | Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900…The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR. | 01/24/2007Terminated |
| Z-0160-2007 | Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station…Injection through the flush port of these ERCP catheters may be compromised due to omission of a… | 10/05/2006Terminated |