Submission Details
| 510(k) Number | K212198 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
Oct 2021
Decision
100d
Days
Class 2
Risk
About This 510(k) Submission
K212198 is an FDA 510(k) clearance for the Tyvek(R) Roll with CI for STERLINKTM Sterilizer, 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 review panel. Regulated under 21 CFR 880.6850.
Device Classification
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6850 |
Manufacturer
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