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 Envision Endoscopy.
FDA 510(k) Cleared Endoscopic Grasping/cutting Instrument, Non-powered Devices (Product Code OCZ)
About Product Code OCZ - Regulatory Context
510(k) Submission Activity
73 total 510(k) submissions under product code OCZ since 1976, with 73 receiving FDA clearance (average review time: 77 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for OCZ submissions have been consistent, averaging 87 days recently vs 77 days historically.
OCZ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →