K192978 is an FDA 510(k) clearance for the EOGas 4 Ethylene Oxide Gas Sterilizer. This device is classified as a Sterilizer, Ethylene-oxide Gas (Class II - Special Controls, product code FLF).
Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on November 12, 2020, 385 days after receiving the submission on October 24, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K192978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2019 |
| Decision Date | November 12, 2020 |
| Days to Decision | 385 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 |