Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suzhou Endophix Co., Ltd. — 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) |
|---|---|---|---|---|---|
| K232941 | Megaloop Button System | Suzhou Endophix Co., Ltd. | 2024-05-03 | 226 | 0 |
| K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Suzhou Endophix Co., Ltd. | 2023-11-02 | 57 | 0 |
| K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knot | Suzhou Endophix Co., Ltd. | 2023-06-07 | 61 | 0 |
| K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sh | Suzhou Endophix Co., Ltd. | 2023-05-23 | 54 | 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