MQX — Needle, Acupuncture, Single Use Class II
FDA product code MQX covers "Needle, Acupuncture, Single Use", a Class II medical device regulated under 21 CFR 880.5580. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MQX
- Device Class
- Class II
- Regulation Number
- 880.5580
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K162566 | changchun aik medical devices co | AIK Sterile Acupuncture Needles for Single Use | May 11, 2017 |
| K142760 | k.s. choi corporation | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | August 25, 2015 |
| K150903 | maanshan bond medical instruments co | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, | July 15, 2015 |
| K142920 | k.m.s | KM Needles (Acupuncture Needle) | June 10, 2015 |
| K141473 | smc intl | SMC ACUPUNCTURE NEEDLE | August 1, 2014 |
| K132896 | asia-med gmbh and co kg | CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, | December 2, 2013 |
| K111392 | woojeon | WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) | November 4, 2011 |
| K103061 | biomate medical devices technology co | BIOMATE STERILE ACUPUNCTURE NEEDLE | June 20, 2011 |
| K092240 | haenglim seowon medical | ACUPUNCTURE NEEDLES | April 21, 2010 |
| K090199 | wuxi jiajian medical instrument co | JIAJIAN ACUPUNCTURE NEEDLE | August 11, 2009 |
| K090910 | hansol medical | HANSO ACUPUNCTURE NEEDLE | June 30, 2009 |
| K071524 | tcm world | TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL | April 10, 2008 |
| K072778 | helio medical supplies | BRIO ACUPUNCTURE NEEDLES | November 19, 2007 |
| K061517 | prime herbs corporation | PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND | November 22, 2006 |
| K062448 | helio medical supplies | LYRA ACUPUNCTURE NEEDLES | September 20, 2006 |
| K060392 | sedatelec | ASP TITANIUM | April 26, 2006 |
| K052731 | daxin li | KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES | February 1, 2006 |
| K052723 | helio medical supplies | SEVEN STAR NEEDLE | January 13, 2006 |
| K052846 | maanshan medical instruments co | TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE | December 22, 2005 |
| K052085 | asia-med gmbh and co kg | STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDL | October 14, 2005 |