FDA.reportPublic FDA data

INTERSCOPE, INC.

Matched from indexed company URL: Interscope, Inc.

FDA Registration(s)#

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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00854172008063EndoRotor® XT Catheter 3.2mm x 1890mm - ER 10-01-OP-S1-800-461-4289info@interscopemed.com
00854172008100EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter - 6.0-PED-EGD1-877-420-7299info@interscopemed.com
00854172008117EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter - 6.0-EPR-EGD1-877-420-7299info@interscopemed.com
00854172008254EndoRotor® Catheter Guide - CATHGUIDE1-877-420-7299info@interscopemed.com
00865830000206EndoRotor® 2200 Catheter - ER 10-031-800-461-4289info@interscopemed.com

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#

GUDID#