Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cook Endoscopy — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192697 | Instinct Plus Endoscopic Clipping Device | Cook Endoscopy | 2020-03-05 | 161 | 0 |
| K090183 | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | Cook Endoscopy | 2009-09-25 | 242 | 0 |
| K083330 | ECHOTIP ULTRA ULTRASOUND NEEDLE | Cook Endoscopy | 2009-02-06 | 86 | 0 |
| K061937 | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | Cook Endoscopy | 2006-12-01 | 144 | 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