Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)— 510(k) K212048

Clearance details

Applicant

Intuitive Surgical, Inc.

Product code

Product code EOQ

Device class

Class 2

Regulation

21 CFR 874.4680

Advisory panel

Ear, Nose, Throat

Date received

2021-06-30

Decision date

2021-08-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sunnyvale, CA, US

• K261637 — Single-use Flexible Bronchoscope2026-09-23
• K260309 — Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set2026-09-16
• K254026 — 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 more2026-09-02
• K260382 — MONARCH Platform (MON-000008)2026-07-25
• K254037 — LungFlow Airway Catheter2026-07-10

• K263592 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)2026-10-30
• K262455 — da Vinci 5 Handheld Camera Head (470080) +4 more2026-10-14
• K261823 — da Vinci Surgical System, Model IS50002026-09-08
• K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)2026-08-07
• K261824 — da Vinci Surgical System, Model IS50002026-07-31

Death

135

Injury

2,863

Malfunction

21,662

Total

24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1134-2026 — Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/AClass II·Ongoing·Intuitive Surgical, Inc.·20251204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212048.