K172749 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 February 9, 2018, 150 days after receiving the submission on September 12, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K172749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2017 |
| Decision Date | February 09, 2018 |
| Days to Decision | 150 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 |