K142920 is an FDA 510(k) clearance for the KM Needles (Acupuncture Needle). This device is classified as a Needle, Acupuncture, Single Use (Class II - Special Controls, product code MQX).
Submitted by K.M.S., Inc. (Cheonan-Si, KR). The FDA issued a Cleared decision on June 10, 2015, 245 days after receiving the submission on October 8, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5580.
| 510(k) Number | K142920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2014 |
| Decision Date | June 10, 2015 |
| Days to Decision | 245 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 |