K192641 is an FDA 510(k) clearance for the Gemini Titan Sterilization Wrap. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on January 24, 2020, 122 days after receiving the submission on September 24, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K192641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2019 |
| Decision Date | January 24, 2020 |
| Days to Decision | 122 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 |