Submission Details
| 510(k) Number | K223025 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2022 |
| Decision Date | May 09, 2023 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Tyvek Roll with CI for STERLINK Sterilizer
May 2023
Decision
222d
Days
Class 2
Risk
About This 510(k) Submission
K223025 is an FDA 510(k) clearance for the Tyvek Roll with CI for STERLINK 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 May 9, 2023, 222 days after receiving the submission on September 29, 2022. 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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