ODF · Class II · 21 CFR 876.1500

FDA Product Code ODF: Mini Endoscope, Gastroenterology-urology

To Examine And Perform Procedures In Body Cavities Of The Gi And Gu Tract. 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).

12
Total
12
Cleared
109d
Avg days
1988
Since

FDA 510(k) Cleared Mini Endoscope, Gastroenterology-urology Devices (Product Code ODF)

12 devices
1–12 of 12
No devices found for this product code.

About Product Code ODF - Regulatory Context