Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lagis Enterprise Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI | Lagis Enterprise Co., Ltd. | 2026-05-20 | 237 | 0 |
| K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | 2025-03-17 | 90 | 0 |
| K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670 | Lagis Enterprise Co., Ltd. | 2024-10-30 | 268 | 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