The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Endoscope Sterilization Tray.
Device ID | K170640 |
510k Number | K170640 |
Device Name: | Endoscope Sterilization Tray |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Building 101 Sunnyvale, CA 94086 |
Contact | Kunal Gunjal |
Correspondent | Kunal Gunjal Intuitive Surgical, Inc. 1266 Kifer Road Building 101 Sunnyvale, CA 94086 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-02 |
Decision Date | 2017-09-17 |
Summary: | summary |