Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Urosurge, 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) |
|---|---|---|---|---|---|
| DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATO | Urosurge, Inc. | 2000-02-09 | 13 | 0 |
| K992391 | UROSURGE SPIRALFLO URETERAL STENT | Urosurge, Inc. | 1999-08-18 | 30 | 0 |
| K981491 | UROSURGE FILASTENT URETERAL STENT | Urosurge, Inc. | 1998-05-29 | 32 | 0 |
| K981489 | UROSURGE SPIRASTENT PLUS URETERAL STENT | Urosurge, Inc. | 1998-05-29 | 32 | 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