K011808 is an FDA 510(k) clearance for the ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX). This device is classified as a Needle, Acupuncture, Single Use (Class II - Special Controls, product code MQX).
Submitted by Asia-Med GmbH and CO KG (Littleton, US). The FDA issued a Cleared decision on July 10, 2001, 29 days after receiving the submission on June 11, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5580.
| 510(k) Number | K011808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2001 |
| Decision Date | July 10, 2001 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MQX — Needle, Acupuncture, Single Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5580 |