FDA Cleared
New Device
Pathway: 510K
Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
Applicant:
Strauss Surgical USA
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
FAJ
Review Panel:
Gastroenterology, Urology
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-09-02
Decision Date:
2026-10-30
Total Review Duration:
58 calendar days (58 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Antonio Nava
Role: SUBMITTER_CONTACT
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