# K171661: Scopis Extended Instrument Set EM

- Pathway: 510(k) (Traditional)
- Applicant: Scopis GmbH
- Decided: Sep 27, 2017 after 114 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: 5 generations back to K983831 (1999). 24 ancestors in all.
3 later devices descend from it; 2 cite it directly.
4 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell, Fiagon GmbH (2014) Summary page 4.
- K092467: Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial Unlimited, Brainlab AG (2010) 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
- K202609: Instrument Clamps Electromagnetic (2020), 0 descendants of its own

## Indications for use
The Scopis Extended Instrument Set 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/K171661
Methodology: https://510kreport.com/methodology