The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for Endoscope Sterilization Tray.
| Device ID | K133942 |
| 510k Number | K133942 |
| Device Name: | ENDOSCOPE STERILIZATION TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | INTUITIVE SURGICAL 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen INTUITIVE SURGICAL 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874113103 | K133942 | 000 |