Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ndo Surgical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
202 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073671 | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUM | Ndo Surgical, Inc. | 2008-03-26 | 90 | 0 |
| K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRU | Ndo Surgical, Inc. | 2007-10-18 | 77 | 0 |
| K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | Ndo Surgical, Inc. | 2007-09-18 | 104 | 0 |
| K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM | Ndo Surgical, Inc. | 2003-10-23 | 43 | 1 |
| K031262 | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 | Ndo Surgical, Inc. | 2003-05-23 | 32 | 0 |
| K023234 | ENDOSCOPIC PLICATION SYSTEM | Ndo Surgical, Inc. | 2003-04-17 | 202 | 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