Wilson-Cook Medical, Inc.: FDA clearances and approvals
Wilson-Cook Medical, Inc. has 125 FDA 510(k) clearances (first 1985, latest 2026), plus 1 De Novo decision, across 41 product codes in 5 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 158 days, against 147 days for all cleared 510(k)s in the same product codes. openFDA lists 45 product recalls by a recalling firm named Wilson-Cook Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 25 |
| 2013 | 1 | 46 |
| 2014 | 2 | 27 |
| 2015 | 0 | — |
| 2016 | 2 | 76 |
| 2017 | 8 | 222 |
| 2018 | 7 | 264 |
| 2019 | 7 | 102 |
| 2020 | 4 | 44 |
| 2021 | 1 | 30 |
| 2022 | 1 | 100 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 116 |
| 2026 | 1 | 246 |
Review time against the same product codes
Since 2017, Wilson-Cook Medical, Inc.'s cleared 510(k)s took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 20 | 20 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 12 | 12 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 12 | 12 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 7 | 7 |
| FCG | Biopsy Needle | 5 | 5 |
| FDX | Endoscopic Cytology Brush | 5 | 5 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 5 | 5 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 4 | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 3 |
| ESW | Prosthesis, Esophageal | 3 | 3 |
Plus 31 more product codes.
Review panels
- Gastroenterology and Urology (109)
- General and Plastic Surgery (11)
- Ear, Nose and Throat (4)
- Anesthesiology (1)
- Dental (1)
Most recent Wilson-Cook Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | QAU | 2026-06-02 | 246 |
| K251104 | SureTome SW Sphincterotome with DomeTip | KNS | 2025-09-29 | 171 |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | KNS | 2025-01-17 | 60 |
| K213356 | Entuit PEG, Entuit PEGJ | PIF | 2022-01-20 | 100 |
| K212323 | Instinct Plus Endoscopic Clipping Device | PKL | 2021-08-25 | 30 |
| K201322 | Entuit Nasal Jejunal Feeding Tube | KNT | 2020-06-17 | 30 |
| K200972 | Hemospray Endoscopic Hemostat | QAU | 2020-06-10 | 58 |
| K200247 | Fusion Quattro Extraction Balloon | GCA | 2020-02-27 | 27 |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | KNS | 2020-01-30 | 155 |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | GCA | 2019-12-13 | 10 |
115 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170015 | De Novo | Hemostatic Device For Endoscopic Gastrointestinal Use | 2018-05-07 |
Recalls
45 product recalls in 31 recall events; 17 initiated in the last five years. Most recent: 2026-08-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Wilson-Cook Medical, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Wilson-Cook Medical, Inc. have?
Wilson-Cook Medical, Inc. has 125 FDA 510(k) clearances (first 1985, latest 2026), plus 1 De Novo decision, across 41 product codes in 5 review panels.
How long does FDA take to clear Wilson-Cook Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Wilson-Cook Medical, Inc.'s cleared 510(k)s is 88 days. Since 2017: 158 days, versus 147 days for all cleared 510(k)s in the same product codes.
What devices does Wilson-Cook Medical, Inc. make?
Its most frequent FDA product codes are FGE (Stents, Drains And Dilators For The Biliary Ducts, 20); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 12); KNT (Tubes, Gastrointestinal (And Accessories), 12).
Has Wilson-Cook Medical, Inc. had device recalls?
openFDA lists 45 product recalls in 31 recall events by a recalling firm whose name matches Wilson-Cook Medical, Inc; the most recent began 2026-08-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 125 Wilson-Cook Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Wilson-Cook Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.