Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K232984 |
Device Name |
Ion Endoluminal System (IF1000) |
Applicant |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Applicant Contact |
Jyoti Singh |
Correspondent |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Correspondent Contact |
Jyoti Singh |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 09/22/2023 |
Decision Date | 12/18/2023 |
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
|
|
|