# K171829: EndoNaut

- Pathway: 510(k) (Traditional)
- Applicant: Therenva Sas
- Decided: Sep 21, 2017 after 93 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913770 (1991). 19 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160088: Cydar EV, Cydar, Ltd. (2016) Summary page 4.

## Most influential descendants
- K212383: EndoNaut (2021), 2 descendants of its own
- K222070: EndoNaut (2022), 1 descendant of its own
- K243432: Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (2025), 0 descendants of its own

## Indications for use
EndoNaut provides image guidance by overlaying preoperative 3D vessel anatomy onto live fluoroscopic images in order to assist in the positioning of the guidewires, catheters and other endovascular devices. EndoNaut is intended to assist endovascular procedures in the thorax, abdomen, neck, pelvis and lower limbs. Suitable procedures include (but not limited to) endovascular aortic aneurysm repair (AAA and TAA), angioplasty, stenting and embolization in iliac arteries and corresponding veins. EndoNaut is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs.

Source page: https://510kreport.com/device/K171829
Methodology: https://510kreport.com/methodology