Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medigus , 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) |
|---|---|---|---|---|---|
| K151001 | MUSE System | Medigus , Ltd. | 2015-06-05 | 51 | 0 |
| K143634 | MUSE System | Medigus , Ltd. | 2015-01-20 | 29 | 0 |
| K132151 | SRS ENDOSCOPIC STAPLING SYSTEM | Medigus , Ltd. | 2014-03-19 | 251 | 0 |
| K120299 | SRS ENDOSCOPIC STAPLING SYSTEM | Medigus , Ltd. | 2012-05-18 | 108 | 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