K172850 is an FDA 510(k) clearance for the SterilContainer with PrimeLine Pro Lid. 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 November 17, 2017, 58 days after receiving the submission on September 20, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K172850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2017 |
| Decision Date | November 17, 2017 |
| Days to Decision | 58 days |
| Submission Type | Special |
| 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 |