# K193118: TGS Guidewire and updated Scopis Software

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Ent
- Decided: Feb 21, 2020 after 101 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K911783 (1994). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161940: Guidewire 0.6 Single Use, Fiagon GmbH (2016) Summary page 4.
- K171661: Scopis Extended Instrument Set EM, Scopis GmbH (2017) Summary page 4.
- K161491: Scopis Hybrid Navigation System EM, Scopis GmbH (2017) Summary page 4.

## Most influential descendants
- K221098: Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit (2022), 0 descendants of its own

## Indications for use
The TGS Guidewire is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT- or MR~ based model of the anatomy. Example procedures include, but are not limited to: + Transsphenoidal access procedures + Intranasal procedures + Sinus procedures, such as maxillary antrostomies, ethmoidectomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies * ENT-related anterior skull base procedures

Source page: https://510kreport.com/device/K193118
Methodology: https://510kreport.com/methodology