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

Advanced Surgical Intervention, Inc. — Predicate Candidate Screening

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

93 daysmedian FDA review time
243 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954215MINIGUARDAdvanced Surgical Intervention, Inc.1996-05-082430
K926110ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENTAdvanced Surgical Intervention, Inc.1993-07-082170
K930361ASI CYSTOLASE LASER CYSTOSCOPEAdvanced Surgical Intervention, Inc.1993-04-29930
K921990ASI UROPLASTY LASER CYSTOSCOPEAdvanced Surgical Intervention, Inc.1992-10-281830
K902585UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETERAdvanced Surgical Intervention, Inc.1990-08-27760
K901336ASI HEMOSTASIS CATHETERAdvanced Surgical Intervention, Inc.1990-06-20900
K896713ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.Advanced Surgical Intervention, Inc.1990-05-241760
K895182ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODYAdvanced Surgical Intervention, Inc.1989-10-24740
K874530URETHRAL DILATOR ENDOSCOPEAdvanced Surgical Intervention, Inc.1988-01-27850

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