FDA Cleared
New Device
Pathway: 510K
Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)
Applicant:
Zhejiang Geyi Medical Instrument Co., Ltd.
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
FGB
Review Panel:
Gastroenterology, Urology
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-07-16
Decision Date:
2026-10-29
Total Review Duration:
105 calendar days (105 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
Cathy Tan
Role: SUBMITTER_CONTACT
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