K092622 is an FDA 510(k) clearance for the STERRAD 100NX STERILIZER EXPRESS CYCLE. 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 March 4, 2011, 555 days after receiving the submission on August 26, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K092622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2009 |
| Decision Date | March 04, 2011 |
| Days to Decision | 555 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 |