K173642 is an FDA 510(k) clearance for the KLOCKNER SURGICAL BOX. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by SOADCO, S.L. (Escaldes-Engordany, AD). The FDA issued a Cleared decision on October 2, 2018, 312 days after receiving the submission on November 24, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K173642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2017 |
| Decision Date | October 02, 2018 |
| Days to Decision | 312 days |
| Submission Type | Abbreviated |
| 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 |