FDA Product Code EOX: Esophagoscope (flexible Or Rigid)
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 Pentax of America, Inc. and Cyted Limited.
FDA 510(k) Cleared Esophagoscope (flexible Or Rigid) Devices (Product Code EOX)
About Product Code EOX - Regulatory Context
510(k) Submission Activity
30 total 510(k) submissions under product code EOX since 1976, with 30 receiving FDA clearance (average review time: 109 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.
EOX devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →