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 Endovations, Olympus America, Inc. and United States Endoscopy Group, Inc..
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 →