MQX — Needle, Acupuncture, Single Use Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K162566changchun aik medical devices coAIK Sterile Acupuncture Needles for Single UseMay 11, 2017
K142760k.s. choi corporationAcuzone Acupuncture Needles, KSC DB Plus Acupuncture NeedlesAugust 25, 2015
K150903maanshan bond medical instruments coEACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING,July 15, 2015
K142920k.m.sKM Needles (Acupuncture Needle)June 10, 2015
K141473smc intlSMC ACUPUNCTURE NEEDLEAugust 1, 2014
K132896asia-med gmbh and co kgCJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, December 2, 2013
K111392woojeonWOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)November 4, 2011
K103061biomate medical devices technology coBIOMATE STERILE ACUPUNCTURE NEEDLEJune 20, 2011
K092240haenglim seowon medicalACUPUNCTURE NEEDLESApril 21, 2010
K090199wuxi jiajian medical instrument coJIAJIAN ACUPUNCTURE NEEDLEAugust 11, 2009
K090910hansol medicalHANSO ACUPUNCTURE NEEDLEJune 30, 2009
K071524tcm worldTCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINALApril 10, 2008
K072778helio medical suppliesBRIO ACUPUNCTURE NEEDLESNovember 19, 2007
K061517prime herbs corporationPRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA ANDNovember 22, 2006
K062448helio medical suppliesLYRA ACUPUNCTURE NEEDLESSeptember 20, 2006
K060392sedatelecASP TITANIUMApril 26, 2006
K052731daxin liKANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLESFebruary 1, 2006
K052723helio medical suppliesSEVEN STAR NEEDLEJanuary 13, 2006
K052846maanshan medical instruments coTEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USEDecember 22, 2005
K052085asia-med gmbh and co kgSTANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLOctober 14, 2005