FDA Product Code OOD: Surgical Film
To Be Implanted To Reinforce Soft Tissue Or Bone Where Weakness Exists. Intended To Be Used Wherever Temporary Wound Support Is Required, To Reinforce Soft Tissues Where Weakness Exists In The Urological, Gynecological, Or Gastrointestinal Anatomy, Or For The Repair Of Hernia Or Other Fascial Defects That Require The Addition Of A Reinforcing Or Bridging Material To Obtain The Desired Surgical Result. The Absorbable Protective Film Also May Help Minimize The Potential For Tissue Attachment To The Device In Case Of Direct Contact With The Viscera.
Leading manufacturers include Tepha, Inc..
FDA 510(k) Cleared Surgical Film Devices (Product Code OOD)
About Product Code OOD - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code OOD since 2007, with 13 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
OOD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →