Wilson-Cook Medical Inc./Cook Endoscopy: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Wilson-Cook Medical Inc./Cook Endoscopy” (first 2012, latest 2019), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 260 days. Since 2017 the median was 260 days, against 155 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 | 2 | 200 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 52 |
| 2018 | 2 | 260 |
| 2019 | 1 | 262 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wilson-Cook Medical Inc./Cook Endoscopy took a median 260 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| NEU | Marker, Radiographic, Implantable | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
Review panels
Most recent Wilson-Cook Medical Inc./Cook Endoscopy 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | FBK | 2019-12-19 | 262 |
| K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords | KNS | 2018-05-24 | 261 |
| K172288 | Fusion OMNI Sphincterotome | KNS | 2018-04-17 | 260 |
| K171993 | Zimmon Needle Knife Papillotome | KNS | 2017-08-17 | 45 |
| K171607 | Bronchi and Gastrointestinal Cytology Brush | FDX | 2017-07-31 | 60 |
| K121505 | DISPOSABLE HEMOSTASIS CHIP | PKL | 2012-08-31 | 102 |
| K111895 | ECHOTIP(R) ULTRA FIDUCIAL NEEDLE | NEU | 2012-04-27 | 297 |
Recalls
openFDA lists no recalls under a recalling firm named Wilson-Cook Medical Inc./Cook Endoscopy.
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./Cook Endoscopy (a text match, not an official crosswalk):
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-Cook Medical, Inc. (125 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wilson-Cook Medical Inc./Cook Endoscopy?
FDA lists 7 510(k) clearances under the applicant name “Wilson-Cook Medical Inc./Cook Endoscopy” (first 2012, latest 2019), across 5 product codes in 2 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./Cook Endoscopy?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wilson-Cook Medical Inc./Cook Endoscopy is 260 days. Since 2017: 260 days, versus 155 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wilson-Cook Medical Inc./Cook Endoscopy?
The most frequent FDA product codes under this applicant name are KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 3); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); FDX (Endoscopic Cytology Brush, 1).
Next steps
- See all 7 Wilson-Cook Medical Inc./Cook Endoscopy clearances with predicates and recalls
- Run predicate analysis for product code KNS, Wilson-Cook Medical Inc./Cook Endoscopy'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.