# K182188: Ion Endoluminal System ; Flexision Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical
- Decided: Feb 14, 2019 after 185 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914181 (1991). 7 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141366: Video Bronchoscope System, Scholly Fiberoptic GmbH (2014) Summary page 4.
- K163537: Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga, Covidien, LLC (2017) Summary page 4.

## Most influential descendants
- K202370: Ion Endoluminal System (2020), 5 descendants of its own
- K220299: Ion Endoluminal System (IF1000) (2022), 4 descendants of its own
- K232984: Ion Endoluminal System (IF1000) (2023), 3 descendants of its own
- K192367: Ion Endoluminal System (2019), 3 descendants of its own
- K242070: Ion Endoluminal System (IF 1000) (2024), 2 descendants of its own

## Recalls of this device
- Jul 12, 2024 · Class II · Z-2720-2024: There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
- Aug 6, 2021 · Class II · Z-0106-2022: Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
- Oct 23, 2020 · Class II · Z-0489-2021: The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
- Jun 10, 2020 · Class II · Z-2950-2020: One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cl
- Jun 10, 2020 · Class II · Z-2949-2020: One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cl

## Indications for use
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use. The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung. The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

Source page: https://510kreport.com/device/K182188
Methodology: https://510kreport.com/methodology