# K212383: EndoNaut

- Pathway: 510(k) (Special)
- Applicant: Therenva Sas
- Decided: Aug 31, 2021 after 29 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: 9 generations back to K913770 (1991). 20 ancestors in all.
2 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)
- K171829: EndoNaut, Therenva Sas (2017) Summary page 4.

## Most influential descendants
- 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 is indicated for the treatment of patients with endovascular diseases and who needs, such as but not limited to the following examples: * endovascular aortic aneurysm repair (AAA and TAA), * angioplasty, * stenting, » embolization in iliac arteries and corresponding veins. EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs.

Source page: https://510kreport.com/device/K212383
Methodology: https://510kreport.com/methodology