FDA Product Code FAK: Panendoscope (gastroduodenoscope)
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 Precision Instrument Corp..
2
Total
2
Cleared
25d
Avg days
1976
Since
FDA 510(k) Cleared Panendoscope (gastroduodenoscope) Devices (Product Code FAK)
2 devices