K231996 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 September 7, 2023, 64 days after receiving the submission on July 5, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K231996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2023 |
| Decision Date | September 07, 2023 |
| Days to Decision | 64 days |
| Submission Type | Special |
| 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 |