K160818 is an FDA 510(k) clearance for the STERRAD® NX Sterilizer with ALLClear™ Technology. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Advanced Sterilization Products (Irvine, US). The FDA issued a Cleared decision on September 27, 2016, 187 days after receiving the submission on March 24, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K160818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2016 |
| Decision Date | September 27, 2016 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |