K183297 is an FDA 510(k) clearance for the Vis-U-All Low Temperature Sterilization Pouch/Tubing. 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 January 3, 2019, 37 days after receiving the submission on November 27, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K183297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2018 |
| Decision Date | January 03, 2019 |
| Days to Decision | 37 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 |