K233222 is an FDA 510(k) clearance for the Aygün Sterilization Container Systems. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Aygun Surgical Instruments Co., Inc. (Kutlukent, TR). The FDA issued a Cleared decision on December 12, 2023, 75 days after receiving the submission on September 28, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K233222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | December 12, 2023 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |