K182414 is an FDA 510(k) clearance for the Aesculap® SterilContainer(TM) S2 System. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 5, 2019, 304 days after receiving the submission on September 4, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K182414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2018 |
| Decision Date | July 05, 2019 |
| Days to Decision | 304 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 |