K152183 is an FDA 510(k) clearance for the EXELINT SecureTouch Safety Hypodermic Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Exelint International, Co. (Redondo Beach, US). The FDA issued a Cleared decision on November 2, 2015, 89 days after receiving the submission on August 5, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K152183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2015 |
| Decision Date | November 02, 2015 |
| Days to Decision | 89 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 |