The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Endoscope Sterilization Tray.
| Device ID | K180964 |
| 510k Number | K180964 |
| 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 | 2018-04-12 |
| Decision Date | 2018-09-28 |
| Summary: | summary |