# K161555: KARL STORZ NAV1 Electromagnetic Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Oct 21, 2016 after 137 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). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 20 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.
- K122096: Karl Storz Navigationpanel Unit (Npu) System, KARL STORZ Endoscopy-America, Inc. (2012) Summary page 4.

## Most influential descendants
- K201174: TruDi Curette (2020), 0 descendants of its own
- K180948: TruDi NAV Suction Instruments (2018), 0 descendants of its own

## Indications for use
The KARL STORZ NAV 1 electromagnetic navigation system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures under visual control. Their use 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 radiological image data or digitized landmarks of the anatomy

Source page: https://510kreport.com/device/K161555
Methodology: https://510kreport.com/methodology