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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Uroscience, Inc. — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

70 daysmedian FDA review time
322 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K001807TISSUE MARKERAdvanced Uroscience, Inc.2001-05-033220
K002573ADVANCED UROSCIENCE INNERSHEATHAdvanced Uroscience, Inc.2000-11-16900
K002323ADVANCED UROSCIENCE INJECTION NEEDLEAdvanced Uroscience, Inc.2000-07-31340
K993459MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXAdvanced Uroscience, Inc.1999-11-05230
K982890ADVANCED UROSCIENCE INJECTION NEEDLEAdvanced Uroscience, Inc.1998-10-26700

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