OCZ · Class II · 21 CFR 876.1500

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.

74
Total
74
Cleared
80d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 180d recently vs 77d historically

FDA 510(k) Cleared Endoscopic Grasping/cutting Instrument, Non-powered Devices (Product Code OCZ)

74 devices
1–24 of 74

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 →