K152458 is an FDA 510(k) clearance for the Gemini Bonded 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 1, 2016, 278 days after receiving the submission on August 28, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K152458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2015 |
| Decision Date | June 01, 2016 |
| Days to Decision | 278 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 |