Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endoscopic Concepts, Inc. — 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) |
|---|---|---|---|---|---|
| K980804 | SABRE BT BLUNT0TIP SURGICAL TROCAR | Endoscopic Concepts, Inc. | 1998-04-01 | 30 | 0 |
| K952977 | SABRE MULTI-USE TROCAR SYSTEM | Endoscopic Concepts, Inc. | 1995-07-17 | 20 | 0 |
| K950500 | BASIC REUSABLE TROCAR SYSTEM | Endoscopic Concepts, Inc. | 1995-02-23 | 17 | 0 |
| K943976 | SABRE ULTIMATE SHIELDED TROCAR | Endoscopic Concepts, Inc. | 1994-09-07 | 23 | 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