K160908 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 July 22, 2016, 112 days after receiving the submission on April 1, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K160908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2016 |
| Decision Date | July 22, 2016 |
| Days to Decision | 112 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 |