Device Listing 1015698327

Listing Summary#

Listing key
1015698327
Premarket submission
K233942
Device
PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )
Applicant
Pentax of America, Inc.
Product code
FDT
Decision date
2024-08-01