Medical device manufacturer
Wilson-Cook Medical Inc.
Wilson-Cook Medical Inc. holds 126 FDA 510(k) clearances across 41 product codes. Median elapsed review time is 88 days. openFDA lists 44 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 126
- Product codes
- 41
- Median review
- 88 days
- Recall records
- 44
How does FDA spell Wilson-Cook Medical Inc.?
FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Wilson Cook Medical | device/510k | normalised |
| Wilson-Cook Medical | device/510k | normalised |
| Wilson-Cook Medical Inc | device/recall | normalised |
| Wilson-Cook Medical Inc. | device/registrationlisting | normalised |
| Wilson-Cook Medical Inc. | device/recall | normalised |
| Wilson-Cook Medical Inc. | device/enforcement | normalised |
| Wilson-Cook Medical, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Wilson-Cook Medical Inc. file in?
41 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 20 | 84 days | |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 12 | 65 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 12 | 119 days | |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 7 | 28 days | |
| FCG | Biopsy Needle | 5 | 122 days | |
| FDX | Endoscopic Cytology Brush | 5 | 159 days | |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 5 | 29 days | |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 4 | 63 days | |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 110 days | |
| ESW | Prosthesis, Esophageal | 3 | 421 days | |
| GAA | Needle, Aspiration And Injection, Disposable | 3 | 14 days | |
| KGE | Forceps, Biopsy, Electric | 3 | 264 days | |
| KNQ | Dilator, Esophageal | 3 | 297 days | |
| LQR | Dislodger, Stone, Biliary | 3 | 88 days | |
| PKL | Hemostatic Metal Clip For The Gi Tract | 3 | 46 days | |
| FCK | Instrument, Biopsy, Suction | 2 | 97 days | |
| FDI | Snare, Flexible | 2 | 90 days | |
| FFX | System, Gastrointestinal Motility (Electrical) | 2 | 145 days | |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 2 | 180 days | |
| KNW | Instrument, Biopsy | 2 | 48 days | |
| LQC | Lithotriptor, Biliary Mechanical | 2 | 17 days | |
| ODC | Endoscope Channel Accessory | 2 | 179 days | |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | 2 | 90 days | |
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | 2 | 58 days | |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 90 days |
Showing the 25 they file in most, of 41.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Wilson-Cook Medical Inc. had a recall?
openFDA lists 44 recall records naming this company across its whole history, of which 3 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-1812-2026Class IIOpen, ClassifiedPKL
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Z-1362-2026Class IIOpen, ClassifiedKNS
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.
Z-1298-2026Class IIOpen, ClassifiedKNT
Nasal feeding tube packaged without the nasal transfer tube component.
Z-0582-2025Class IIOpen, ClassifiedQAU
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.
Z-0036-2025Class IIOpen, ClassifiedQAU
Specific lots of product have been manufactured with nonconforming raw materials.
Showing the 5 most recently initiated of 44.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Wilson-Cook Medical Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | QAU | 246 | |
| K251104 | SureTome SW Sphincterotome with DomeTip | KNS | 171 | |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | KNS | 60 | |
| K213483 | SnapLoc Wire Lock | ODC | 179 | |
| K213356 | Entuit PEG, Entuit PEGJ | PIF | 100 | |
| K212323 | Instinct Plus Endoscopic Clipping Device | PKL | 30 | |
| K201322 | Entuit Nasal Jejunal Feeding Tube | KNT | 30 | |
| K200972 | Hemospray Endoscopic Hemostat | QAU | 58 | |
| K200247 | Fusion Quattro Extraction Balloon | GCA | 27 | |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | KNS | 155 |
Source: openFDA device/510k · retrieved
Where is Wilson-Cook Medical Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Wilson-Cook Medical Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.