K222440 is an FDA 510(k) clearance for the Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on September 9, 2022, 28 days after receiving the submission on August 12, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K222440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2022 |
| Decision Date | September 09, 2022 |
| Days to Decision | 28 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 |