OSV — Insufflator, Endoscopic Vessel Harvesting Class II

FDA Device Classification

FDA product code OSV covers "Insufflator, Endoscopic Vessel Harvesting", a Class II medical device regulated under 21 CFR 884.1730. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
OSV
Device Class
Class II
Regulation Number
884.1730
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.