# Cook Endoscopy

- Location (FDA's records): Winston-Salem, NC
- FDA decisions: 5 (2003–2020): 4 510(k) clearances and 1 original PMA approval
- Product codes: KNQ (2), PKL (1), FCG (1), MVG (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 11 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wilson-Cook Medical, Inc.: 4 (https://510kreport.com/company/wilson-cook-medical)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Medi-Globe Corp.: 1 (https://510kreport.com/company/medi-globe)
- Ximed/Prosure/Injectx: 1 (https://510kreport.com/company/ximed-prosure-injectx)

## Firms that cite its devices most
- Cook Ireland, Ltd.: 4 (https://510kreport.com/company/cook-ireland)
- Wilson-Cook Medical, Inc.: 2 (https://510kreport.com/company/wilson-cook-medical)
- Wilson-Cook Medical Inc./Cook Endoscopy: 1 (https://510kreport.com/company/wilson-cook-medical-cook-endoscopy)
- Boston Endoscopic Engineering: 1 (https://510kreport.com/company/boston-endoscopic-engineering)
- Covidien, LLC ( Formerly Beacon Endoscopic Corp.): 1 (https://510kreport.com/company/covidien-formerly-beacon-endoscopic)
- Lb Medical LLC: 1 (https://510kreport.com/company/lb-medical)
- Mauna Kea Technologies: 1 (https://510kreport.com/company/mauna-kea-technologies)

## Its most-cited devices
- K083330: Echotip Ultra Ultrasound Needle (2009), cited by 9
- K061937: Cook Endoscopy Esophageal Dilation Balloon (2006), cited by 1
- K192697: Instinct Plus Endoscopic Clipping Device (2020), cited by 1

## Recent decisions
- K192697: Instinct Plus Endoscopic Clipping Device (Mar 5, 2020)
- K090183: Hercules 3 Stage Wire Guided Dilation Balloon (Sep 25, 2009)
- K083330: Echotip Ultra Ultrasound Needle (Feb 6, 2009)
- K061937: Cook Endoscopy Esophageal Dilation Balloon (Dec 1, 2006)
- P020021: Wizard X-Cell Photodynamic Therapy Balloon with Fiber Optic Diffuser (Aug 1, 2003)

Source page: https://510kreport.com/company/cook-endoscopy