K023290 is an FDA 510(k) clearance for the STERRAD 50 & STERRAD 100S STERILIZERS. This device is classified as a Sterilizer, Ethylene-oxide Gas (Class II - Special Controls, product code FLF).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on April 3, 2003, 183 days after receiving the submission on October 2, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K023290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2002 |
| Decision Date | April 03, 2003 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLF — Sterilizer, Ethylene-oxide Gas |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |