K162566 is an FDA 510(k) clearance for the AIK Sterile Acupuncture Needles for Single Use. This device is classified as a Needle, Acupuncture, Single Use (Class II - Special Controls, product code MQX).
Submitted by Changchun Aik Medical Devices Co., Ltd. (Changchun, CN). The FDA issued a Cleared decision on May 11, 2017, 239 days after receiving the submission on September 14, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5580.
| 510(k) Number | K162566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2016 |
| Decision Date | May 11, 2017 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MQX — Needle, Acupuncture, Single Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5580 |