Device Classification Name |
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
|
510(k) Number |
K180964 |
Device Name |
Endoscope Sterilization Tray |
Applicant |
Intuitive Surgical, Inc. |
1266 Kifer Road, Building 101 |
Sunnyvale,
CA
94086
|
|
Applicant Contact |
Kunal Gunjal |
Correspondent |
Intuitive Surgical, Inc. |
1266 Kifer Road, Building 101 |
Sunnyvale,
CA
94086
|
|
Correspondent Contact |
Kunal Gunjal |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 04/12/2018 |
Decision Date | 09/28/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|