K231500 is an FDA 510(k) clearance for the Vis-U-All Low Temperature Sterilization Pouches. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 7, 2023, 75 days after receiving the submission on May 24, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K231500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2023 |
| Decision Date | August 07, 2023 |
| Days to Decision | 75 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 |