K221379 is an FDA 510(k) clearance for the Steriking LT-Blueline Pouches with Tyvek. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Wipak OY (Nastola, FI). The FDA issued a Cleared decision on January 4, 2023, 237 days after receiving the submission on May 12, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K221379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2022 |
| Decision Date | January 04, 2023 |
| Days to Decision | 237 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 |