K162993 is an FDA 510(k) clearance for the Gemini Sterilization Wrap. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 23, 2017, 239 days after receiving the submission on October 27, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K162993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2016 |
| Decision Date | June 23, 2017 |
| Days to Decision | 239 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 |