K170039 is an FDA 510(k) clearance for the STERRAD VELOCITY Biological Indictator and Reader. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Advanced Sterilization Products (Asp) (Irvin, US). The FDA issued a Cleared decision on June 20, 2017, 166 days after receiving the submission on January 5, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K170039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2017 |
| Decision Date | June 20, 2017 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |