K231291 is an FDA 510(k) clearance for the Perforated Baskets. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on June 3, 2024, 396 days after receiving the submission on May 4, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K231291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2023 |
| Decision Date | June 03, 2024 |
| Days to Decision | 396 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 |