FDA Product Code OCZ: Endoscopic Grasping/cutting Instrument, Non-powered
To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.
Leading manufacturers include Karl Storz SE & CO. KG, C.R. Bard, Inc. and Baxter Healthcare Corp.
FDA 510(k) Cleared Endoscopic Grasping/cutting Instrument, Non-powered Devices (Product Code OCZ)
About Product Code OCZ - Regulatory Context
510(k) Submission Activity
74 total 510(k) submissions under product code OCZ since 1976, with 74 receiving FDA clearance (average review time: 80 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - OCZ Product Code
Recent submissions under OCZ have taken an average of 180 days to reach a decision - up from 77 days historically. Manufacturers should account for longer review timelines in current project planning.
OCZ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →