Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K212048 |
Device Name |
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) |
Applicant |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Applicant Contact |
Jennifer Siu |
Correspondent |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Correspondent Contact |
Jennifer Siu |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 06/30/2021 |
Decision Date | 08/26/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|