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.

Scopis · Ear, Nose, and Throat Stereotaxic Instrument → Neurology

Name: Scopis
Brand: Scopis

3manufacturers in China registered for this device type

3catalogue numbers in this listing

1recall

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 Scopis
Listed by	Stryker Leibinger Gmbh & Co. KG, Germany
FDA product code	PGW
Device type	Ear, Nose, And Throat Stereotaxic Instrument
Device class	Class 2
Regulation	21 CFR 882.4560
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2022-10-20

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Scopis
Catalogue number	Size	Status
8000-021-005		In distribution
8000-021-001		In distribution
8000-021-002		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

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Scopis
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Stryker Leibinger Gmbh & Co. KG	UDI-DI	2024-04-04	Class II	Software Manufacturing/Software Deployment	Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.	705 units

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.

Scopis