K111392 is an FDA 510(k) clearance for the WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE). This device is classified as a Needle, Acupuncture, Single Use (Class II - Special Controls, product code MQX).
Submitted by Woojeon Company (Pittsburgh, US). The FDA issued a Cleared decision on November 4, 2011, 170 days after receiving the submission on May 18, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5580.
| 510(k) Number | K111392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2011 |
| Decision Date | November 04, 2011 |
| Days to Decision | 170 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 |