K232625 is an FDA 510(k) clearance for the Steriking® Pouch for Robotic Instruments. 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 June 7, 2024, 283 days after receiving the submission on August 29, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K232625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2023 |
| Decision Date | June 07, 2024 |
| Days to Decision | 283 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 |