Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Uresil, LLC — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093653 | URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK | Uresil, LLC | 2010-02-23 | 90 | 0 |
| K053245 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATH | Uresil, LLC | 2005-12-20 | 29 | 0 |
| K041995 | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI- | Uresil, LLC | 2004-08-19 | 27 | 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