FDA Product Code FEB: Accessories, Cleaning, For Endoscope
If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
Leading manufacturers include STERIS Corporation and Wassenburg Medical, Inc..
FDA 510(k) Cleared Accessories, Cleaning, For Endoscope Devices (Product Code FEB)
About Product Code FEB - Regulatory Context
510(k) Submission Activity
57 total 510(k) submissions under product code FEB since 1981, with 57 receiving FDA clearance (average review time: 209 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FEB have taken an average of 132 days to reach a decision - down from 212 days historically, suggesting improved FDA processing for this classification.
FEB devices are reviewed by the General Hospital panel. Browse all General Hospital devices →