FDA Cleared
New Device
Pathway: 510K
RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
Applicant:
Smith & Nephew Medical, Ltd.
SNN
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
OMP
Review Panel:
General, Plastic Surgery
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-01-30
Decision Date:
2026-10-30
Total Review Duration:
273 calendar days (273 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
Kerry Greig
Role: SUBMITTER_CONTACT
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