K172095 is an FDA 510(k) clearance for the Autokeeper. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Medexel Co.,Ltd (Anseong-Si, KR). The FDA issued a Cleared decision on July 24, 2018, 378 days after receiving the submission on July 11, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K172095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2017 |
| Decision Date | July 24, 2018 |
| Days to Decision | 378 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |