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 |