Submission Details
| 510(k) Number | K162007 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 20, 2016 |
| Decision Date | February 16, 2017 |
| Days to Decision | 211 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
STERRAD NX Sterilizer
Feb 2017
Decision
211d
Days
Class 2
Risk
About This 510(k) Submission
K162007 is an FDA 510(k) clearance for the STERRAD NX Sterilizer, a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on February 16, 2017, 211 days after receiving the submission on July 20, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.
Device Classification
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6860 |
Manufacturer
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