K212198 is an FDA 510(k) clearance for the Tyvek(R) Roll with CI for STERLINKTM Sterilizer. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on October 22, 2021, 100 days after receiving the submission on July 14, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K212198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2021 |
| Decision Date | October 22, 2021 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |