Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Surgical Concepts (Asc) — 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) |
|---|---|---|---|---|---|
| K011183 | OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE | Advanced Surgical Concepts (Asc) | 2001-06-15 | 58 | 0 |
| K010711 | ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR | Advanced Surgical Concepts (Asc) | 2001-05-22 | 74 | 0 |
| K002013 | OMNIPORT | Advanced Surgical Concepts (Asc) | 2000-09-29 | 88 | 0 |
| K993544 | SPACE-OR RETRACTOR | Advanced Surgical Concepts (Asc) | 1999-12-22 | 64 | 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