Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011697028

FEI Number

3011697028

Entity Name

INTERSCOPE, INC.

City/State/Country

Northbridge, MA, US

Establishment Address

200 Commerce Dr., Northbridge, MA 01534, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INTERSCOPE., INC (Owner Number: 10054826)

Owner / Operator Contact Address

200 Commerce Dr, Northbridge, MA 01534, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN200016

PMA Number

N/A

All Registered Proprietary Names

EPR-TRAP EndoRotor® Specimen Trap ESS-CONSOLE EndoRotor® EndoSurgery System - Console 3.2-EPR-BRO-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Bronchoscope 3.2-PED-BRO-O EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Bronchoscope EPR-TRAP EndoRotor® Specimen Trap 3.2-EPR-COL-OP EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Colonoscope Long Olympus/Pentax CATHGUIDE EndoRotor® Catheter Guide 3.2-EPR-EGD-F EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Gastroscope Fuji 6-EPR-EGD EndoRotor® 6mm Endoscopic Powered Resection (EPR) Catheter ESS-CONSOLE EndoRotor® EndoSurgery System - Console 3.2-EPR-COL-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Colonoscope Short Olympus 3.2-EPR-EGD-OP EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Gastroscope Olympus/Pentax 3.7-PED-EGD-F EndoRotor® 3.7mm Powered Endoscopic Debridement (PED) Catheter Gastroscope Fuji ESS-CONSOLE EndoRotor® EndoSurgery System - Console 3.2-PED-EGD-OP EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Gastroscope Olympus/Pentax 3.2-PED-COL-OP EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Colonoscope Long Olympus/Pentax 3.2-PED-EGD-F EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Gastroscope Fuji PED-PURGE EndoRotor® Purge Kit 3.7-PED-EGD-OP EndoRotor® 3.7mm Powered Endoscopic Debridement (PED) Catheter Gastroscope Olympus/Pentax 6-PED-EGD EndoRotor® 6mm Powered Endoscopic Debridement (PED) Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2020-12-17
PTE	Endoscopic Morcellator Gastroenterology	Obstetrics/Gynecology	Class 2	884.1690	2022-02-15
QNE	Endoscopic Pancreatic Debridement Device	Gastroenterology, Urology	Class 2	876.4330	2021-02-18

Official Correspondent

JEFFERY RYAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTERSCOPE., INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011697028. Last updated year: 2026. Please use registration number 3011697028 when referencing this establishment in official correspondence.