Company ยท US
Cook Endoscopy
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2020. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 5 |
| KNQ | Dilator, Esophageal | 4 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 |
| KOG | 2 | |
| MND | Ligator, Esophageal | 2 |
| FCG | Biopsy Needle | 1 |
| FHN | Ligator, Hemorrhoidal | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2020 | K192697 | Instinct Plus Endoscopic Clipping Device Cook Endoscopy | PKL |
| Sep 25, 2009 | K090183 | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON Cook Endoscopy | KNQ |
| Feb 6, 2009 | K083330 | ECHOTIP ULTRA ULTRASOUND NEEDLE Cook Endoscopy | FCG |
| Dec 1, 2006 | K061937 | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON Cook Endoscopy | KNQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2011 | Cook Endoscopy Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical
Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of en Terminated |
MND | K023903 |
| Jan 19, 2011 | Cook Endoscopy DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105
This device is intended to guide both optical and accessory devices for diagnostic Terminated |
FGE | K101095 |
| Jan 19, 2011 | Cook Endoscopy DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105
This device is intended to guide both optical and accessory devices for diagnostic and therapeuti Terminated |
FGE | K101095 |
| Oct 19, 2010 | Cook Endoscopy Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105
This device is used to endoscopically ligate esophageal varices at or above the g Terminated |
MND | K944220 |
| Oct 19, 2010 | Cook Endoscopy Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105
This device is used to endoscopically ligate esophageal varices at or above the g Terminated |
FHN | K974018 |
| Sep 1, 2009 | Cook Endoscopy Jejunal Feeding Set, Product Order number FLOWJ-9-20.
This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support. Terminated |
KNT | K920703 |
| Jul 21, 2009 | Cook Endoscopy Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Terminated |
KNS | K052051 |
| Mar 10, 2009 | Cook Endoscopy AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, packed 5 boxes, 10 units per box.
This device is used wi Terminated |
KNS | K851958 |
| Jan 5, 2009 | Cook Endoscopy FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Techn Terminated |
KNS | K052051 |
| Oct 14, 2008 | Cook Endoscopy Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, N Terminated |
FGE | K020788 |
| Sep 23, 2008 | Cook Endoscopy Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Used Terminated |
FGE | K851962 |
| Sep 23, 2008 | Cook Endoscopy Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC Terminated |
FGE | K851962 |
| Feb 22, 2007 | Cook Endoscopy Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 Terminated |
KNQ | K935094 |
| Nov 8, 2006 | Cook Endoscopy Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 Terminated |
KOG | K932205 |
| May 6, 2006 | Cook Endoscopy Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook ***
Large product lab Terminated |
KOG | None listed |
| Jan 25, 2006 | Cook Endoscopy SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable Terminated |
KNQ | K851955 |