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

TruDi Shaver Blade

Name: TruDi Shaver Blade
Brand: TruDi Shaver Blade

TruDi Shaver Blades cut and remove soft tissue, hard tissue or bone during ENT, maxillofacial, head and neck or skull base surgery. They are used with the Bien-Air S120 handpiece and TruDi…

Registry build 21.09.26

TruDi Shaver Blades cut and remove soft tissue, hard tissue or bone during ENT, maxillofacial, head and neck or skull base surgery. They are used with the Bien-Air S120 handpiece and TruDi Navigation System when rigid anatomical landmarks can be related to a CT or MR model.

A sensor integrated at the blade’s distal tip is tracked within the navigation system’s low energy magnetic field. The system displays the tip position over the patient’s preoperative images, helping the surgeon locate anatomical structures during tissue removal.

Listed Item

Trudi Shaver Blade 4.0mm – Straight (0°)- 5pk

Blade Configurations

The sterile single use blades are available straight or at 15, 40 and 60 degree angles. Operation requires the compatible Bien-Air S120 handpiece and OSSEODUO control unit, together with TruDi navigation.

3manufacturers in China registered for this device type

4catalogue numbers in this listing

8510(k) clearances naming this product code

5recalls on this 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 TruDi Shaver Blade
Listed by	Acclarent, Inc., United States
FDA product code	PGW
Device type	Ear, Nose, And Throat Stereotaxic Instrument
Device class	Class 2
Regulation	21 CFR 882.4560
Establishment	Specification developer, Manufacturer
510(k)	K221037
Record published	2022-09-09
Record revised	2024-11-21 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Store in a cool, dry place
Packaging	Box of 5

Catalogue Numbers

Catalogue numbers for TruDi Shaver Blade
Catalogue number	Size	Status
TSB4STR		In distribution
TSB460		In distribution
TSB415		In distribution
TSB440		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
Scopis	Stryker Leibinger Gmbh & Co. KG	3

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
K231862	2023-07-21
K221037	2022-07-20
K201174	2020-08-12
K193453	2020-03-23
K190532	2019-05-03
K180948	2018-07-20
K173628	2018-03-10
K161697	2016-10-24

Recalls

5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2023-09-21	Class II	Software Design Change	When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT s	141
2021-11-12	Class II	Process control	Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to	1543
2019-03-06	Class II	Device Design	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
2019-03-06	Class II	Device Design	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
2019-03-06	Class II	Device Design	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.	14 Suction Insstruments

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.