Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fci Sas (France Chirurgie Instrumentation) · 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) |
|---|---|---|---|---|---|
| K130375 | SELF-RETAINING BICANALICULUS INTUBATON SET II | Fci Sas (France Chirurgie Instrumentation) | 2013-12-04 | 293 | 0 |
| K121142 | CRAWFORD BIOCANALICULUS INTUBATION | Fci Sas (France Chirurgie Instrumentation) | 2012-08-09 | 115 | 0 |
| K113536 | MASTERKA 40 MASTERKA 35 MASTERKA 30 | Fci Sas (France Chirurgie Instrumentation) | 2012-08-03 | 247 | 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