K151725 is an FDA 510(k) clearance for the STERRAD NX Sterilizer, STERRAD 100NX Sterilizer. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on January 13, 2016, 201 days after receiving the submission on June 26, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K151725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2015 |
| Decision Date | January 13, 2016 |
| Days to Decision | 201 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 |