The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Ion Endoluminal System (if1000).
| Device ID | K220299 |
| 510k Number | K220299 |
| Device Name: | Ion Endoluminal System (IF1000) |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Jyoti Singh |
| Correspondent | Jyoti Singh 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 | 2022-02-02 |
| Decision Date | 2022-06-16 |