Wilson-Cook Medical, Inc.: FDA filings under this applicant name
FDA lists 126 510(k) clearances under 3 spellings of the applicant name “Wilson-Cook Medical, Inc.” (first 1985, latest 2026), plus 1 De Novo decision, across 41 product codes in 5 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 164 days, against 147 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Cook Medical, based on public ownership records.
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 | 2 | 140 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 116 |
| 2026 | 1 | 246 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wilson-Cook Medical, Inc. took a median 164 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 (110)
- 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 |
| K213483 | SnapLoc Wire Lock | ODC | 2022-04-26 | 179 |
| 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 |
116 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Wilson-Cook Medical, Inc. (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Wilson-Cook Medical, Inc. (125)
- Wilson Cook Medical (1)
- Wilson-Cook Medical (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wilson Greatbatch Technologies, Inc. (9 510(k)s)
- Wilson-Cook Medical Inc./Cook Endoscopy (7 510(k)s)
- Wilson Biomedical, Inc. (2 510(k)s)
- Wilson Glove Products Co., Ltd. (2 510(k)s)
- Wilson Instruments (Shanghai) Company Limited (2 510(k)s)
- Wilson Hunt Intl./, Ltd. (1 510(k)s)
- Wilson Instruments (Sha) Co., Ltd. (1 510(k)s)
- Wilson Medical Instruments Co. (1 510(k)s)
- Wilson Tech (International) Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wilson-Cook Medical, Inc.?
FDA lists 126 510(k) clearances under 3 spellings of the applicant name “Wilson-Cook Medical, Inc.” (first 1985, latest 2026), plus 1 De Novo decision, across 41 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wilson-Cook Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wilson-Cook Medical, Inc. is 88 days. Since 2017: 164 days, versus 147 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wilson-Cook Medical, Inc.?
The most frequent FDA product codes under this applicant name 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).
Next steps
- See all 126 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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.