What is FDA product code PGW?

Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

Neurology › SurgicalEar, Nose, And Throat Stereotaxic Instrument

Integrated Headrest

Name: Integrated Headrest
Brand: Integrated Headrest

The Integrated Headrest is mounted on the procedure chairs. It comprises a holder for a Navigation sensor, which creates an electromagnetic field above the cushion of the Integrated…

Registry build 21.09.26

The Integrated Headrest is mounted on the procedure chairs. It comprises a holder for a Navigation sensor, which creates an electromagnetic field above the cushion of the Integrated Headrest. The Integrated Headrest comes with the following adapters: 1) Chair Adapter 4020 2) Chair Adapter 2512.

3manufacturers in China registered for this device type

1catalogue number

11510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PGW
Manufacturer	City	Province	Registered as	Device types
Modern Medical Equipment Manufacturing Ltd.	Heng Li, Dongguan	Guangdong	Contract manufacturer	26
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd	Qing Yuan	Guangdong	Contract manufacturer	26

Record

Regulatory record for Integrated Headrest
Listed by	Fiagon GMBH, Germany
FDA product code	PGW
Device type	Ear, Nose, And Throat Stereotaxic Instrument
Device class	Class 2
Regulation	21 CFR 882.4560
Establishment	Manufacturer
Record published	2025-06-25

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Integrated Headrest
Catalogue number	Size	Status
E011970		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ear, Nose, And Throat Stereotaxic Instrument	Karl Storz GmbH & Co. KG	17
StealthStation	Medtronic Navigation, Inc.	17
Medtronic Navigation	Medtronic Navigation, Inc.	14
Ear, Nose, And Throat Stereotaxic Instrument	Medtronic Navigation, Inc.	13
Ear, Nose, And Throat Stereotaxic Instrument	Stryker Leibinger Gmbh & Co. KG	12
StealthStation Cranial Software	Medtronic Navigation, Inc.	11
AxiEM™	Medtronic Navigation, Inc.	10
Profess	Stryker Leibinger Gmbh & Co. KG	8
TGS	Stryker GmbH	6
StealthStation S8	Medtronic Navigation, Inc.	5
TruDi Probe	Acclarent, Inc.	4
TruDi Shaver Blade	Acclarent, Inc.	4

Showing 12 of 94. All products under Ear, Nose, And Throat Stereotaxic Instrument

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K261540	2026-06-02
K211291	2021-07-19
K200041	2020-03-10
K163416	2017-02-16
K162176	2016-12-01
K161940	2016-09-18
K160479	2016-03-23
K160369	2016-03-10
K150473	2015-04-16
K141456	2014-10-08
K133573	2014-04-30

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.