Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Entrigue Surgical, 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) |
|---|---|---|---|---|---|
| K130354 | MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR | Entrigue Surgical, Inc. | 2013-05-29 | 106 | 0 |
| K121351 | SINUS DILATION SYSTEM | Entrigue Surgical, Inc. | 2012-08-29 | 117 | 0 |
| K082750 | ENTACT SEPTAL STAPLER, MODEL 610-00100 | Entrigue Surgical, Inc. | 2009-01-06 | 109 | 0 |
| K072470 | BIOELAST 5-0 SUTURE, MODEL 500100 | Entrigue Surgical, Inc. | 2007-11-16 | 73 | 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