The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Ion Endoluminal System (ion Fully Articulating Catheter), Ion Endoluminal System (ion Peripheral Vision Probe).
| Device ID | K212048 |
| 510k Number | K212048 |
| Device Name: | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Jennifer Siu |
| Correspondent | Jennifer Siu Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2021-08-26 |