CorPath GRX Control Console

FDA UDI

Class II (US FDA UDI)

by Corindus, Inc.

Identity

Trade Name: CorPath GRX Control Console FDA UDI
Generic Name: Cardiac mapping system workstation FDA UDI
Model / Reference: 301 FDA UDI

Identifiers

Catalog Number: 301 FDA UDI
Primary DI / UDI-DI: 00816280023017 FDA UDI
510(k) Number: K160121 FDA UDI
K173288 FDA UDI
K202275 FDA UDI
FDA Product Code: DXX FDA UDI
GMDN Term: Cardiac mapping system workstation FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1290 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac mapping system workstation

CorPath GRX Control Console by Corindus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system workstation.

Cardiodrive Hemostasis Adapter - SJ — Stereotaxis, Inc. · Class II
Cinema MAS & MMS — Stereotaxis, Inc. · Class I
Odyssey Enterprise Interface — Stereotaxis, Inc. · Class I
vMap Disposables — Vektor Medical, Inc. · Class II
QuikCAS Hemostasis Adapter — Stereotaxis, Inc. · Class II
Cardiodrive System — Stereotaxis, Inc. · Class II
Navigant — Stereotaxis, Inc. · Class II
Odyssey — Stereotaxis, Inc. · Class I

Cleared under the same submission

K160121 also covers:

K173288 also covers:

K202275 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Corindus, Inc.

Sources (1)

FDA UDI 321a92e7-cf38-457c-b0c4-d559f6c29237 36 fields · synced Jun 8, 2026