K162162 is an FDA 510(k) clearance for the Barrier Supreme Sterilization Wrapper. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 4, 2016, 94 days after receiving the submission on August 2, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K162162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2016 |
| Decision Date | November 04, 2016 |
| Days to Decision | 94 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 |