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).
Leading manufacturers include Boston Scientific Corp.
12
Total
12
Cleared
109d
Avg days
1988
Since
FDA 510(k) Cleared Mini Endoscope, Gastroenterology-urology Devices (Product Code ODF)
12 devices
Cleared
Feb 04, 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
Boston Scientific Corp
Gastroenterology & Urology
12d
Cleared
Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
Boston Scientific Corp
Gastroenterology & Urology
13d
Cleared
Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
Boston Scientific Corp
Gastroenterology & Urology
15d