K183139 is an FDA 510(k) clearance for the Endoscope Sterilization Tray. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 1, 2019, 80 days after receiving the submission on November 13, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K183139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2018 |
| Decision Date | February 01, 2019 |
| Days to Decision | 80 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |