Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GEJ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
101 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240185 | Cypris eXact Suture Placement Device | Cypris Medical | 2024-05-03 | 101 | 0 |
| K900958 | GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM | Solos Endoscopy, Inc. | 1990-04-18 | 50 | 0 |
| K900959 | GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED | Solos Endoscopy, Inc. | 1990-04-18 | 50 | 0 |
| K884553 | STAMEY NEEDLE | Cook Ob/Gyn | 1988-11-14 | 14 | 0 |
| K874342 | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE | Cox-Uphuff Intl. | 1987-11-13 | 24 | 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