K201533 is an FDA 510(k) clearance for the Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Avinent Implant System S.L.U. (Santpedor, ES). The FDA issued a Cleared decision on March 1, 2021, 266 days after receiving the submission on June 8, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K201533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2020 |
| Decision Date | March 01, 2021 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| 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 |