CorPath GRX Drive Gear

FDA UDI

Class II (US FDA UDI)

by Corindus, Inc.

Identity

Trade Name: CorPath GRX Drive Gear FDA UDI
Generic Name: Cardiac mapping system workstation FDA UDI
Model / Reference: 307 FDA UDI

Identifiers

Catalog Number: 307 FDA UDI
Primary DI / UDI-DI: 00816280023079 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac mapping system workstation

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

Similar devices

Also classified as Cardiac mapping system workstation.

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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

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Manufacturer

Manufacturer: Corindus, Inc.

Sources (1)

FDA UDI 3f063b3e-9747-43ca-9f23-85aeea498263 36 fields · synced May 30, 2026