FDA Product Code FDA: Enteroscope And Accessories
To Provide Visualization And Perform Various Procedures Within The Small Intestine. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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 Aspero Medical, Inc., Fujifilm Healthcare Americas Corporation and Fujifilm Corporation.
FDA 510(k) Cleared Enteroscope And Accessories Devices (Product Code FDA)
About Product Code FDA - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code FDA since 1981, with 20 receiving FDA clearance (average review time: 142 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FDA have taken an average of 170 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.
FDA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →