Device
EndoNaut (system) (EndoNaut (Standalone) SW v1.2 + EndoNaut Workstation model: TS1CA2DS1-2)
Manufacturer
THERENVA
THERENVA
Model: 1.2
DI: 03760262480046
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
EndoNaut (system) (EndoNaut (Standalone) SW v1.2 + EndoNaut Workstation model: TS1CA2DS1-2)
Note: the version is characterized by the main medical software which bears the medical features). EndoNaut Workstation is an accessory to the main medical device EndoNaut (Standalone) SW.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
73248b72-8afc-4613-b975-14467baada88
Distribution Status:
In Commercial Distribution
DUNS Number:
296780716
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
03760262480046
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61496
Name: Surgical planning/navigation-enhancement system
Definition:
A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.
FDA Product Codes
OWB
Interventional Fluoroscopic X-Ray System
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K222070
Supplement Number:
000