Submission Details
| 510(k) Number | K231500 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2023 |
| Decision Date | August 07, 2023 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Vis-U-All Low Temperature Sterilization Pouches
Aug 2023
Decision
75d
Days
Class 2
Risk
About This 510(k) Submission
K231500 is an FDA 510(k) clearance for the Vis-U-All Low Temperature Sterilization Pouches, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 7, 2023, 75 days after receiving the submission on May 24, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.
Device Classification
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6850 |
Manufacturer
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