FDA.reportPublic FDA data

INTERSCOPE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116970283011697028INTERSCOPE, INC.1N2026-01-01200 Commerce Dr. Northbridge MA US 01534

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2074531751857103K190715EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll StandERL2019-12-13
2074531436155798K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot ControlPTE2019-01-03
2074531099782047K170120EndoRotorPTE2017-04-18
2074531581187357DEN200016EndoRotor DeviceQNE2020-12-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PTE22019-01-03
QNE12020-12-23
ERL12019-12-13

PMN#