The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Instrument And Accessories Sterilization Trays.
| Device ID | K072211 |
| 510k Number | K072211 |
| Device Name: | INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Michael H Yramategui |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-09 |
| Decision Date | 2008-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874113462 | K072211 | 000 |
| 00886874113455 | K072211 | 000 |