Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wilson-Cook Medical Inc./Cook Endoscopy · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
260 daysmedian FDA review time
297 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Wilson-Cook Medical Inc./Cook Endoscopy | 2019-12-19 | 262 | 0 |
| K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sp | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-05-24 | 261 | 0 |
| K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-04-17 | 260 | 0 |
| K171993 | Zimmon Needle Knife Papillotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-08-17 | 45 | 0 |
| K171607 | Bronchi and Gastrointestinal Cytology Brush | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-07-31 | 60 | 0 |
| K121505 | DISPOSABLE HEMOSTASIS CHIP | Wilson-Cook Medical Inc./Cook Endoscopy | 2012-08-31 | 102 | 0 |
| K111895 | ECHOTIP(R) ULTRA FIDUCIAL NEEDLE | Wilson-Cook Medical Inc./Cook Endoscopy | 2012-04-27 | 297 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda