K092745 is an FDA 510(k) clearance for the VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on November 19, 2010, 437 days after receiving the submission on September 8, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K092745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2009 |
| Decision Date | November 19, 2010 |
| Days to Decision | 437 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |