FDA Product Code OCV: Endoscope Holder
To Hold Endoscope In A Desired Position During Procedures.
Leading manufacturers include Aktormed GmbH and KARL STORZ Endoscopy-America, Inc..
FDA 510(k) Cleared Endoscope Holder Devices (Product Code OCV)
About Product Code OCV - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code OCV since 1981, with 10 receiving FDA clearance (average review time: 138 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under OCV have taken an average of 244 days to reach a decision - up from 126 days historically. Manufacturers should account for longer review timelines in current project planning.
OCV devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →