FDA Product Code LRO: General Surgery Tray
This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
Leading manufacturers include Medline Industries, Inc..
FDA 510(k) Cleared General Surgery Tray Devices (Product Code LRO)
About Product Code LRO - Regulatory Context
510(k) Submission Activity
110 total 510(k) submissions under product code LRO since 1984, with 110 receiving FDA clearance (average review time: 142 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LRO devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →