# K161491: Scopis Hybrid Navigation System EM

- Pathway: 510(k) (Traditional)
- Applicant: Scopis GmbH
- Decided: Feb 9, 2017 after 253 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: 4 generations back to K911783 (1994). 13 ancestors in all.
3 later devices descend from it; 3 cite it directly.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133573: Fiagon Navigation System, Fiagon GmbH (2014) Summary page 4.

## Most influential descendants
- K193118: TGS Guidewire and updated Scopis Software (2020), 1 descendant of its own
- K221098: Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit (2022), 0 descendants of its own
- K193502: TGS Universal Headrest with Mounting Arm (2020), 0 descendants of its own

## Indications for use
The Scopis Hybrid Navigation System EM 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 the following ENT procedures: • 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/K161491
Methodology: https://510kreport.com/methodology