Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Innovations Corp. · 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) |
|---|---|---|---|---|---|
| K944292 | SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL S | Surgical Innovations Corp. | 1994-11-15 | 74 | 0 |
| K934105 | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | Surgical Innovations Corp. | 1994-03-28 | 217 | 0 |
| K914098 | LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR | Surgical Innovations Corp. | 1991-10-28 | 46 | 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