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

MapperFrame

Name: MapperFrame
Brand: MapperFrame

The product MapperFrame supports the Automatic Registration process for image guided surgery procedures with the Fiagon Navigation System. The MapperFrame is a reusable device. It can be…

Registry build 21.09.26

The product MapperFrame supports the Automatic Registration process for image guided surgery procedures with the Fiagon Navigation System. The MapperFrame is a reusable device. It can be used with a surgical sterile drape in the operating area. The MapperFrame is improper for treatment by autoclave or other sterilization procedures. The MapperFrame is intended to be used in connection with the iPad Remote Control.

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 MapperFrame
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	2017-11-21
Record revised	2023-09-18 (version 6)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 15 to 35 °C
Distribution end date	2023-07-18
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for MapperFrame
Catalogue number	Size	Status
1		Withdrawn

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.