FDA Product Code OCT: Anti Fog Solution And Accessories, Endoscopy
To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.
Leading manufacturers include Uv One Hygienics, Inc. and Batrik Medical Manufacturing, Inc..
FDA 510(k) Cleared Anti Fog Solution And Accessories, Endoscopy Devices (Product Code OCT)
About Product Code OCT - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code OCT since 1991, with 27 receiving FDA clearance (average review time: 163 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
FDA review times for OCT submissions have been consistent, averaging 142 days recently vs 164 days historically.
OCT devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →