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

Endoscope Tracker EM

Name: Endoscope tracker EM
Brand: Endoscope tracker EM

The Endoscope tracker EM provides a way to track the location of compatible conventional rigid endoscopes. The location of the instrument is referenced relative to a patient tracker. The…

Registry build 21.09.26

The Endoscope tracker EM provides a way to track the location of compatible conventional rigid endoscopes. The location of the instrument is referenced relative to a patient tracker. The Endoscope tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Endoscope tracker EM is provided non-sterile and is intended to be sterilized by the user. The Endoscope tracker EM is reusable.

3manufacturers in China registered for this device type

1catalogue number

2510(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 Endoscope tracker EM
Listed by	Scopis GmbH, Germany
FDA product code	PGW
Device type	Ear, Nose, And Throat Stereotaxic Instrument
Device class	Class 2
Regulation	21 CFR 882.4560
Record published	2018-01-04
Record revised	2023-09-18 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Endoscope tracker EM
Catalogue number	Size	Status
1.0		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
K171661	2017-09-27
K161491	2017-02-09

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.