Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fci (France Chirurgie Instrumentation) Sas · 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) |
|---|---|---|---|---|---|
| K212741 | EZYPOR | Fci (France Chirurgie Instrumentation) Sas | 2022-06-24 | 298 | 0 |
| K203569 | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight | Fci (France Chirurgie Instrumentation) Sas | 2021-06-11 | 186 | 0 |
| K201892 | Ritleng®+ and Ritleng®+ PVP | Fci (France Chirurgie Instrumentation) Sas | 2021-03-11 | 246 | 0 |
| K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) Sas | 2020-12-18 | 186 | 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