FDA Product Code OCW: Endoscopic Tissue Approximation Device
To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
Leading manufacturers include Covidien, Apollo Endosurgery, Inc. and Envision Endoscopy.
FDA 510(k) Cleared Endoscopic Tissue Approximation Device Devices (Product Code OCW)
About Product Code OCW - Regulatory Context
510(k) Submission Activity
70 total 510(k) submissions under product code OCW since 1994, with 70 receiving FDA clearance (average review time: 118 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under OCW have taken an average of 165 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.
OCW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →