Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neosurgical, Ltd. — 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) |
|---|---|---|---|---|---|
| K173917 | neoClose PDS | Neosurgical, Ltd. | 2018-11-08 | 321 | 0 |
| K142903 | neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US | Neosurgical, Ltd. | 2014-11-12 | 37 | 0 |
| K131688 | NEOCLOSE HASSON, NEOCLOSE UNIVERSAL | Neosurgical, Ltd. | 2013-07-18 | 38 | 0 |
| K123280 | NEOCLOSE HASSON, NEOCLOSE UNIVERSAL | Neosurgical, Ltd. | 2013-04-18 | 178 | 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