Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imagyn Surgical · 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) |
|---|---|---|---|---|---|
| K021174 | ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR | Imagyn Surgical | 2003-04-29 | 382 | 0 |
| K011575 | 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 | Imagyn Surgical | 2001-08-17 | 87 | 0 |
| K993936 | 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAS | Imagyn Surgical | 1999-12-27 | 38 | 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