Wilson-Cook Medical Inc./Cook Endoscopy
Winston-Salem, NC, US
Wilson-Cook Medical Inc./Cook Endoscopy appears in FDA device records in Winston-Salem, NC. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Wilson-Cook Medical Inc./Cook Endoscopy between 2012 and 2019. The busiest year on record is 2012, with 2. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | FBK | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K172288 | Fusion OMNI Sphincterotome | KNS | Substantially Equivalent | |
| K171993 | Zimmon Needle Knife Papillotome | KNS | Substantially Equivalent | |
| K171607 | Bronchi and Gastrointestinal Cytology Brush | FDX | Substantially Equivalent | |
| K121505 | DISPOSABLE HEMOSTASIS CHIP | PKL | Substantially Equivalent | |
| K111895 | ECHOTIP(R) ULTRA FIDUCIAL NEEDLE | NEU | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain