Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal Syste…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212048 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ion Endoluminal System comprises a fully articulating catheter and a peripheral vision probe, designed for endoscopic navigation and visualization within the pulmonary tract. The Ion Fully Articulating Catheter features a flexible, shape-sensing design with a 2 mm working channel, enabling precise manipulation and access to airway structures. The Ion Peripheral Vision Probe integrates a 120° field-of-view camera to provide real-time visual feedback during procedures. Together, these components facilitate targeted interventions such as biopsies and diagnostic assessments in the lower respiratory tract.
The Ion Endoluminal System is intended for use in clinical settings requiring bronchoscopic procedures, including operating rooms and procedural suites. The fully articulating catheter and peripheral vision probe are supplied as a reusable system, with the catheter featuring a minimum length of 100 cm and compatibility with third-party tools adhering to the same dimensional specifications. The system operates under FDA clearance via a 510(k) submission (K212048), classified under the Ear, Nose, and Throat advisory committee. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What clinical procedures is the Ion Endoluminal System primarily designed to assist with in the lower respiratory tract?
The Ion Endoluminal System is designed to assist with bronchoscopic procedures, such as targeted biopsies and diagnostic assessments within the pulmonary tract. Its fully articulating catheter and peripheral vision probe enable precise navigation and real-time visualization, making it suitable for interventions requiring detailed airway access.
Is the Ion Endoluminal System reusable, and if so, what are the key features of its design that support this?
Yes, the Ion Endoluminal System is supplied as a reusable system. The Ion Fully Articulating Catheter features a flexible, shape-sensing design with a 2 mm working channel, allowing for repeated use while maintaining precise manipulation. The system’s compatibility with third-party tools of matching dimensions further supports its reusable nature.
What is the minimum length of the Ion Fully Articulating Catheter, and how does this length factor into its intended use?
The Ion Fully Articulating Catheter has a minimum length of 100 cm, which provides sufficient reach for navigating and accessing deeper airway structures during bronchoscopic procedures. This length ensures flexibility in clinical settings, including operating rooms and procedural suites, where extended reach may be required.
Does the Ion Endoluminal System include any imaging capabilities, and if so, how does this enhance procedural guidance?
Yes, the Ion Endoluminal System includes the Ion Peripheral Vision Probe, which features a 120° field-of-view camera. This provides real-time visual feedback during procedures, improving precision and reducing reliance on external imaging. The enhanced visualization helps clinicians navigate complex airway anatomy and perform targeted interventions with greater confidence.
How was the Ion Endoluminal System’s regulatory pathway determined, and what advisory committee was involved in its review?
The Ion Endoluminal System received FDA clearance through a 510(k) submission (K212048), classified under the Ear, Nose, and Throat (EN) advisory committee. The decision was based on a determination of substantial equivalence to a predicate device, as outlined in the submission details. This pathway ensures the system meets regulatory standards for bronchoscopic applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Ion Endoluminal System - Intuitive Surgical, How the Ion Endoluminal System Works | Intuitive, Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212048 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K212048 24 fields · synced Sep 19, 2026