K141473 is an FDA 510(k) clearance for the SMC ACUPUNCTURE NEEDLE. This device is classified as a Needle, Acupuncture, Single Use (Class II - Special Controls, product code MQX).
Submitted by Smc Intl., Inc. (Seoul, KR). The FDA issued a Cleared decision on August 1, 2014, 59 days after receiving the submission on June 3, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5580.
| 510(k) Number | K141473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2014 |
| Decision Date | August 01, 2014 |
| Days to Decision | 59 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 |