K143729 is an FDA 510(k) clearance for the SterilContainer S. 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 August 18, 2015, 232 days after receiving the submission on December 29, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K143729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2014 |
| Decision Date | August 18, 2015 |
| Days to Decision | 232 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 |