# K222070: EndoNaut

- Pathway: 510(k) (Traditional)
- Applicant: Therenva Sas
- Decided: Oct 25, 2022 after 103 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: 10 generations back to K913770 (1991). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212383: EndoNaut, Therenva Sas (2021) Summary page 5.
- K160376: EndoSize, Therenva Sas (2016) Summary page 5.
- (no number) EndoNaut workstation: named in the summary without a submission number

## Most influential descendants
- K243432: Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (2025), 0 descendants of its own

## Indications for use
EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. EndoNaut is indicated for use by Physicians for patients undergoing a fluoroscopy X-ray guided procedure in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm repair, artery/vein embolization, or peripheral artery disease treatment. The information provided by the software or system is in no way intended to substitute for, in whole or in part, the surgeon's judgment and analysis of the patient's condition. It is mandatory to check the real-time anatomy with a suitable imaging technique, such as a contrast-enhanced angiography, before deploying any invasive medical device.

Source page: https://510kreport.com/device/K222070
Methodology: https://510kreport.com/methodology