510(k) K212048 ยท EOQ Bronchoscope (Flexible Or Rigid)
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 26, 2021 |
| Received | Jun 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2026 | Intuitive Surgical, Inc. 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 platf Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.