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INTERSCOPE, INC.

USA · Northbridge

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 3 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 2Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: INTERSCOPE, INC.

FDA 510(k) clearances by year

12017 · K170120

22019 · K190715

12020 · DEN200016

FDA listed device types

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Endoscopic Pancreatic Debridement Device 1Endoscopic Morcellator Gastroenterology 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	DEN200016	EndoRotor Device	2020-12-23
US	K190715	EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand	2019-12-13
US	K181127	EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control	2019-01-03

INTERSCOPE, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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