FDA 510(k) Applications for Medical Device Product Code "MQX"
(Needle, Acupuncture, Single Use)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K990729 | ACC INTL. | FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES | 05/13/1999 |
| K960769 | ACU-MED, INC. | ACUPUNCTURE NEEDLE PACK | 07/10/1996 |
| K962419 | ACUPUNCTURE SUPPLIES IMPORT CO. | CW-DISPOSABLE ACUPUNCTURE NEEDLE | 07/25/1996 |
| K962787 | ACUPUNCTURE SUPPLIES IMPORT CO. | TAKI DISPOSABLE ACUPUNCTURE NEEDLE | 07/26/1996 |
| K011248 | ACUSUPPLY, INC. | CW DISPOSABLE ACUPUNCTURE NEEDLE | 10/29/2001 |
| K011247 | ACUSUPPLY, INC. | HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE | 10/17/2001 |
| K011242 | ACUSUPPLY, INC. | HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE | 09/11/2001 |
| K980471 | AMERICAN INSTITUTE OF KORYO HAND THERAPY | KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE | 04/09/1998 |
| K974527 | AMERICAN INSTITUTE OF KORYO HAND THERAPY | KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE | 01/13/1998 |
| K980472 | AMERICAN INSTITUTE OF KORYO HAND THERAPY | KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE | 04/09/1998 |
| K980470 | AMERICAN INSTITUTE OF KORYO HAND THERAPY | KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE | 04/06/1998 |
| K980469 | AMERICAN INSTITUTE OF KORYO HAND THERAPY | KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE | 04/03/1998 |
| K002910 | ANC IMPORT & EXPORT CO. LTD. | HOLY DRAGON ACUPUNCTURE NEEDLES | 02/07/2001 |
| K000740 | ASAHI IRYOKI CO. LTD | ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S | 04/12/2000 |
| K042063 | ASIA-MED GMBH & CO. KG. - WERK SUHL | PRESS TACK NEEDLE | 10/14/2004 |
| K011808 | ASIA-MED GMBH AND CO KG | ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) | 07/10/2001 |
| K132896 | ASIA-MED GMBH AND CO KG | CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE | 12/02/2013 |
| K031716 | ASIA-MED GMBH AND CO KG | SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE | 07/10/2003 |
| K052085 | ASIA-MED GMBH AND CO KG | STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES | 10/14/2005 |
| K103061 | BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. | BIOMATE STERILE ACUPUNCTURE NEEDLE | 06/20/2011 |
| K041652 | C.A.I. INDUSTRIES CORP. | ACUPUNCTURE NEEDLES | 12/29/2004 |
| K970574 | C.A.I. INDUSTRIES CORP. | ACUPUNCTURE NEEDLES | 04/24/1997 |
| K964861 | C.A.M. SUPPLY, INC. | ACUPUNCTURE NEEDLES | 05/29/1997 |
| K162566 | CHANGCHUN AIK MEDICAL DEVICES CO., LTD | AIK Sterile Acupuncture Needles for Single Use | 05/11/2017 |
| K052731 | DAXIN LI | KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES | 02/01/2006 |
| K972659 | DONG BANG, U.S.A. | DONG BANG ACUPUNCTURE NEEDLES | 10/17/1997 |
| K972658 | DONG BANG, U.S.A. | MAGI ACUPUNCTURE NEEDLES | 10/17/1997 |
| K981272 | ELECTRO THERAPEUTIC DEVICES, INC. | ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES | 08/24/1998 |
| K031818 | FACILAI ENTERPRISES LTD. | FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE | 12/03/2003 |
| K011669 | H F INTL. CO. | BW ACUPUNCTURE NEEDLES | 07/09/2001 |
| K002827 | HAENGLIM SEOWON CORP. | MAC ACUPUNCTURE NEEDLE | 02/28/2001 |
| K092240 | HAENGLIM SEOWON MEDICAL CO. | ACUPUNCTURE NEEDLES | 04/21/2010 |
| K090910 | HANSOL MEDICAL CO. | HANSO ACUPUNCTURE NEEDLE | 06/30/2009 |
| K012583 | HELIO MEDICAL SUPPLIES, INC. | ACUGLIDE BRAND ACUPUNCTURE NEEDLES | 12/11/2001 |
| K991508 | HELIO MEDICAL SUPPLIES, INC. | ACUMASTER BRAND ACUPUNCTURE NEEDLE | 08/27/1999 |
| K072778 | HELIO MEDICAL SUPPLIES, INC. | BRIO ACUPUNCTURE NEEDLES | 11/19/2007 |
| K043277 | HELIO MEDICAL SUPPLIES, INC. | C&G ACUPUNCTURE NEEDLE | 02/08/2005 |
| K961339 | HELIO MEDICAL SUPPLIES, INC. | CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES | 07/03/1996 |
| K991507 | HELIO MEDICAL SUPPLIES, INC. | KANGNIAN BRAND ACUPUNCTURE NEEDLE | 08/27/1999 |
| K062448 | HELIO MEDICAL SUPPLIES, INC. | LYRA ACUPUNCTURE NEEDLES | 09/20/2006 |
| K050295 | HELIO MEDICAL SUPPLIES, INC. | PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES | 03/25/2005 |
| K052723 | HELIO MEDICAL SUPPLIES, INC. | SEVEN STAR NEEDLE | 01/13/2006 |
| K024207 | HELIO MEDICAL SUPPLIES, INC. | VINCO BRAND ACUPUNCTURE NEEDLE | 04/14/2003 |
| K012501 | HUMMINGBIRD MEDICAL TECHNOLOGY, L.L.C. | H.M.T. ACUPUNCTURE NEEDLE | 12/11/2001 |
| K142920 | K.M.S. INC. | KM Needles (Acupuncture Needle) | 06/10/2015 |
| K961677 | K.S. CHOI CORP. | ACUPUNCTURE NEEDLES | 10/28/1996 |
| K142760 | K.S. Choi Corporation | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | 08/25/2015 |
| K980899 | KENSHIN TRADING CORP. | JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID | 06/11/1998 |
| K964529 | LHASA MEDICAL, INC. | CW ACUPUNCTURE NEEDLES | 01/30/1997 |
| K963300 | LHASA MEDICAL, INC. | DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES) | 09/23/1996 |
| K031250 | LHASA MEDICAL, INC. | DBC PRESS ACUPUNCTURE NEEDLES | 07/15/2003 |
| K962916 | LHASA MEDICAL, INC. | HUA-XIA ACUPUNCTURE NEEDLES | 08/23/1996 |
| K963299 | LHASA MEDICAL, INC. | HWA-TO ACUPUNCTURE NEEDLES | 09/30/1996 |
| K031060 | LHASA MEDICAL, INC. | NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES | 07/11/2003 |
| K003760 | LHASA MEDICAL, INC. | TAI-CHI ACUPUNCTURE NEEDLES | 02/06/2001 |
| K023787 | LHASA MEDICAL, INC. | TAI-CHI AND MASTER ACUPUNCTURE NEEDLES | 02/14/2003 |
| K964411 | LHASA MEDICAL, INC. | TAKI ACUPUNCTURE NEEDLES | 12/31/1996 |
| K974616 | LORAC, INC. | SINGER ACUPUNCTURE NEEDLES | 02/05/1998 |
| K150903 | MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural | 07/15/2015 |
| K052846 | MAANSHAN MEDICAL INSTRUMENTS CO., LTD. | TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE | 12/22/2005 |
| K000581 | MAEDA TOYOKICHI SHOTEN | MAEDA NEW NEEDLE DISPOSABLE | 02/23/2001 |
| K021904 | MAEDA TOYOKICHI SHOTEN | MAEDA SILVER ACUPUNCTURE NEEDLE | 08/14/2002 |
| K023054 | MANDALA HEALTH CARE, LLC | JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE | 11/13/2002 |
| K043506 | MARKNEW PRODUCTS | ACUPUNCTURE NEEDLES | 02/11/2005 |
| K020880 | MARKNEW PRODUCTS | MARKNEW PRODUCTS ACUPUNCTURE NEEDLES | 06/10/2002 |
| K990328 | MORNING STAR, DONG BANG ACUPUNCTURE U.S.A., INC. | DBC, DONG BANG ACUPUNCTURE NEEDLES | 05/04/1999 |
| K963194 | OMS MEDICAL SUPPLIES, INC. | ITO ACUPUNCTURE NEEDLES | 08/23/1996 |
| K061517 | PRIME HERBS CORPORATION | PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES | 11/22/2006 |
| K964051 | S-TCM ENTERPRISES, INC. | NEEDLE, ACUPUNCTURE | 11/05/1996 |
| K974122 | SCIENTIFIC HEALTH CARE | ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA | 01/22/1998 |
| K060392 | SEDATELEC | ASP TITANIUM | 04/26/2006 |
| K983800 | SEDATELEC | DN ACUPUNTURE NEEDLES | 08/27/1999 |
| K983798 | SEDATELEC | SEDATELEC ASP ACUPUNCTURE NEEDLES | 08/27/1999 |
| K962809 | SEIRIN-AMERICA, INC. | SEIRIN ACUPUNCTURE NEEDLES | 08/16/1996 |
| K970260 | SEIRIN-AMERICA, INC. | SEIRIN JR ACUPUNCTURE NEEDLES | 02/10/1997 |
| K970254 | SEIRIN-AMERICA, INC. | SEIRIN PYONEX ACUPUNCTURE NEEDLES | 02/10/1997 |
| K963769 | SEIRIN-AMERICA, INC. | SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES | 10/16/1996 |
| K002411 | SHENLING MEDICAL DEVICE CO., LTD | SHENLING ACUPUNCTURE NEEDLES | 12/12/2000 |
| K141473 | SMC INTL., INC. | SMC ACUPUNCTURE NEEDLE | 08/01/2014 |
| K030190 | SUZHOU SEN SEN MEDICAL SUPPLIES LTD. | CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES | 02/21/2003 |
| K003748 | SUZHOU TIANYI ACUPUNCTURE INSTRUMENTS CO., LTD. | TIANXIE | 01/26/2001 |
| K983671 | TCM SUPPLY CORP. | NATURAL BRAND ACUPUNCTURE NEEDLES | 03/04/1999 |
| K000816 | TCM SUPPLY CORP. | SHARP BRAND ACUPUNCTURE NEEDLES | 05/04/2000 |
| K071524 | TCM WORLD INC. | TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL | 04/10/2008 |
| K990406 | UNITED PACIFIC CO., LTD. | KINGLI ACUPUNCTURE NEEDLE | 04/16/1999 |
| K001718 | UNITED PACIFIC CO., LTD. | MILLENNIA ACUPUNCTURE NEEDLE | 06/21/2000 |
| K003010 | UNITED PACIFIC CO., LTD. | SPIRIT ACUPUNCTURE NEEDLE | 10/19/2000 |
| K111392 | WOOJEON COMPANY | WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) | 11/04/2011 |
| K021095 | WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD. | HOLY DRAGON BRAND ACUPUNCTURE NEEDLES | 05/17/2002 |
| K013926 | WUJIANG CITY SHENLI MEDICAL AND HEALTH MATERIAL CO | QIZHOU ACUPUNCTURE NEEDLE | 07/18/2002 |
| K090199 | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. | JIAJIAN ACUPUNCTURE NEEDLE | 08/11/2009 |
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