Product Code: MQX FDA class 2 21 CFR 880.5580

Needle, Acupuncture, Single Use

General Hospital

The Single-Use Acupuncture Needle is a general hospital device consisting of a sterile, single-use fine needle used for the practice of acupuncture, in which needles are inserted at specific anatomical points to produce therapeutic effects. Classified as FDA Class 2 under 21 CFR 880.5580 in the General Hospital specialty, it is 510(k)-exempt and subject to general controls. The product code is MQX.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MQX
Device Class: FDA class 2
Regulation Number: 880.5580
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 91 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162566	AIK Sterile Acupuncture Needles for Single Use	May 11, 2017	Substantially Equivalent	Changchun Aik Medical Devices Co., Ltd.
K142760	Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles	Aug 25, 2015	Substantially Equivalent	K.S. Choi Corporation
K150903	EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural	Jul 15, 2015	Substantially Equivalent	Maanshan Bond Medical Instruments Co., Ltd.
K142920	KM Needles (Acupuncture Needle)	Jun 10, 2015	Substantially Equivalent	K.M.S., Inc.
K141473	SMC ACUPUNCTURE NEEDLE	Aug 01, 2014	Substantially Equivalent	Smc Intl., Inc.
K132896	CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE	Dec 02, 2013	Substantially Equivalent	Asia-Med GmbH and CO KG
K111392	WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)	Nov 04, 2011	Substantially Equivalent	Woojeon Company
K103061	BIOMATE STERILE ACUPUNCTURE NEEDLE	Jun 20, 2011	Substantially Equivalent	Biomate Medical Devices Technology Co., Ltd.
K092240	ACUPUNCTURE NEEDLES	Apr 21, 2010	Substantially Equivalent	Haenglim Seowon Medical Co.
K090199	JIAJIAN ACUPUNCTURE NEEDLE	Aug 11, 2009	Substantially Equivalent	Wuxi Jiajian Medical Instrument Co., Ltd.
K090910	HANSO ACUPUNCTURE NEEDLE	Jun 30, 2009	Substantially Equivalent	Hansol Medical Co.
K071524	TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL	Apr 10, 2008	Substantially Equivalent	Tcm World, Inc.
K072778	BRIO ACUPUNCTURE NEEDLES	Nov 19, 2007	Substantially Equivalent	Helio Medical Supplies, Inc.
K061517	PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES	Nov 22, 2006	Substantially Equivalent	Prime Herbs Corporation
K062448	LYRA ACUPUNCTURE NEEDLES	Sep 20, 2006	Substantially Equivalent	Helio Medical Supplies, Inc.
K060392	ASP TITANIUM	Apr 26, 2006	Substantially Equivalent	Sedatelec
K052731	KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES	Feb 01, 2006	Substantially Equivalent	Daxin LI
K052723	SEVEN STAR NEEDLE	Jan 13, 2006	Substantially Equivalent	Helio Medical Supplies, Inc.
K052846	TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE	Dec 22, 2005	Substantially Equivalent	Maanshan Medical Instruments Co., Ltd.
K052085	STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES	Oct 14, 2005	Substantially Equivalent	Asia-Med GmbH and CO KG
K050295	PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES	Mar 25, 2005	Substantially Equivalent	Helio Medical Supplies, Inc.
K043506	ACUPUNCTURE NEEDLES	Feb 11, 2005	Substantially Equivalent	Marknew Products
K043277	C&G ACUPUNCTURE NEEDLE	Feb 08, 2005	Substantially Equivalent	Helio Medical Supplies, Inc.
K041652	ACUPUNCTURE NEEDLES	Dec 29, 2004	Substantially Equivalent	C.A.I. Industries Corp.
K042063	PRESS TACK NEEDLE	Oct 14, 2004	Substantially Equivalent	Asia-Med GmbH & Co. Kg. - Werk Suhl
K031818	FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE	Dec 03, 2003	Substantially Equivalent	Facilai Enterprises , Ltd.
K031250	DBC PRESS ACUPUNCTURE NEEDLES	Jul 15, 2003	Substantially Equivalent	Lhasa Medical, Inc.
K031060	NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES	Jul 11, 2003	Substantially Equivalent	Lhasa Medical, Inc.
K031716	SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE	Jul 10, 2003	Substantially Equivalent	Asia-Med GmbH and CO KG
K024207	VINCO BRAND ACUPUNCTURE NEEDLE	Apr 14, 2003	Substantially Equivalent	Helio Medical Supplies, Inc.
K030190	CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES	Feb 21, 2003	Substantially Equivalent	Suzhou Sen Sen Medical Supplies , Ltd.
K023787	TAI-CHI AND MASTER ACUPUNCTURE NEEDLES	Feb 14, 2003	Substantially Equivalent	Lhasa Medical, Inc.
K023054	JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE	Nov 13, 2002	Substantially Equivalent	Mandala Health Care, LLC
K021904	MAEDA SILVER ACUPUNCTURE NEEDLE	Aug 14, 2002	Substantially Equivalent	Maeda Toyokichi Shoten
K013926	QIZHOU ACUPUNCTURE NEEDLE	Jul 18, 2002	Substantially Equivalent	Wujiang City Shenli Medical and Health Material CO
K020880	MARKNEW PRODUCTS ACUPUNCTURE NEEDLES	Jun 10, 2002	Substantially Equivalent	Marknew Products
K021095	HOLY DRAGON BRAND ACUPUNCTURE NEEDLES	May 17, 2002	Substantially Equivalent	Wujiang City Hua Xin Medical Appliance Co., Ltd.
K012583	ACUGLIDE BRAND ACUPUNCTURE NEEDLES	Dec 11, 2001	Substantially Equivalent	Helio Medical Supplies, Inc.
K012501	H.M.T. ACUPUNCTURE NEEDLE	Dec 11, 2001	Substantially Equivalent	Hummingbird Medical Technology, LLC
K011248	CW DISPOSABLE ACUPUNCTURE NEEDLE	Oct 29, 2001	Substantially Equivalent	Acusupply, Inc.
K011247	HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE	Oct 17, 2001	Substantially Equivalent	Acusupply, Inc.
K011242	HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE	Sep 11, 2001	Substantially Equivalent	Acusupply, Inc.
K011808	ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)	Jul 10, 2001	Substantially Equivalent	Asia-Med GmbH and CO KG
K011669	BW ACUPUNCTURE NEEDLES	Jul 09, 2001	Substantially Equivalent	H F Intl. Co.
K002827	MAC ACUPUNCTURE NEEDLE	Feb 28, 2001	Substantially Equivalent	Haenglim Seowon Corp.
K000581	MAEDA NEW NEEDLE DISPOSABLE	Feb 23, 2001	Substantially Equivalent	Maeda Toyokichi Shoten
K002910	HOLY DRAGON ACUPUNCTURE NEEDLES	Feb 07, 2001	Substantially Equivalent	Anc Import & Export Co. , Ltd.
K003760	TAI-CHI ACUPUNCTURE NEEDLES	Feb 06, 2001	Substantially Equivalent	Lhasa Medical, Inc.
K003748	TIANXIE	Jan 26, 2001	Substantially Equivalent	Suzhou Tianyi Acupuncture Instruments Co., Ltd.
K002411	SHENLING ACUPUNCTURE NEEDLES	Dec 12, 2000	Substantially Equivalent	Shenling Medical Device Co., Ltd.
K003010	SPIRIT ACUPUNCTURE NEEDLE	Oct 19, 2000	Substantially Equivalent	United Pacific Co., Ltd.
K001718	MILLENNIA ACUPUNCTURE NEEDLE	Jun 21, 2000	Substantially Equivalent	United Pacific Co., Ltd.
K000816	SHARP BRAND ACUPUNCTURE NEEDLES	May 04, 2000	Substantially Equivalent	Tcm Supply Corp.
K000740	ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S	Apr 12, 2000	Substantially Equivalent	Asahi Iryoki Co., Ltd.
K991508	ACUMASTER BRAND ACUPUNCTURE NEEDLE	Aug 27, 1999	Substantially Equivalent	Helio Medical Supplies, Inc.
K991507	KANGNIAN BRAND ACUPUNCTURE NEEDLE	Aug 27, 1999	Substantially Equivalent	Helio Medical Supplies, Inc.
K983800	DN ACUPUNTURE NEEDLES	Aug 27, 1999	Substantially Equivalent	Sedatelec
K983798	SEDATELEC ASP ACUPUNCTURE NEEDLES	Aug 27, 1999	Substantially Equivalent	Sedatelec
K990729	FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES	May 13, 1999	Substantially Equivalent	Acc Intl.
K990328	DBC, DONG BANG ACUPUNCTURE NEEDLES	May 04, 1999	Substantially Equivalent	Morning Star, Dong Bang Acupuncture U.S.A., Inc.
K990406	KINGLI ACUPUNCTURE NEEDLE	Apr 16, 1999	Substantially Equivalent	United Pacific Co., Ltd.
K983671	NATURAL BRAND ACUPUNCTURE NEEDLES	Mar 04, 1999	Substantially Equivalent	Tcm Supply Corp.
K981272	ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES	Aug 24, 1998	Substantially Equivalent	Electro Therapeutic Devices, Inc.
K980899	JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID	Jun 11, 1998	Substantially Equivalent	Kenshin Trading Corp.
K980472	KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE	Apr 09, 1998	Substantially Equivalent	American Institute of Koryo Hand Therapy
K980471	KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE	Apr 09, 1998	Substantially Equivalent	American Institute of Koryo Hand Therapy
K980470	KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE	Apr 06, 1998	Substantially Equivalent	American Institute of Koryo Hand Therapy
K980469	KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE	Apr 03, 1998	Substantially Equivalent	American Institute of Koryo Hand Therapy
K974616	SINGER ACUPUNCTURE NEEDLES	Feb 05, 1998	Substantially Equivalent	Lorac, Inc.
K974122	ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA	Jan 22, 1998	Substantially Equivalent	Scientific Health Care
K974527	KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE	Jan 13, 1998	Substantially Equivalent	American Institute of Koryo Hand Therapy
K972659	DONG BANG ACUPUNCTURE NEEDLES	Oct 17, 1997	Substantially Equivalent	Dong Bang, U.S.A.
K972658	MAGI ACUPUNCTURE NEEDLES	Oct 17, 1997	Substantially Equivalent	Dong Bang, U.S.A.
K964861	ACUPUNCTURE NEEDLES	May 29, 1997	Substantially Equivalent	C.A.M. Supply, Inc.
K970574	ACUPUNCTURE NEEDLES	Apr 24, 1997	Substantially Equivalent	C.A.I. Industries Corp.
K970260	SEIRIN JR ACUPUNCTURE NEEDLES	Feb 10, 1997	Substantially Equivalent	Seirin-America, Inc.
K970254	SEIRIN PYONEX ACUPUNCTURE NEEDLES	Feb 10, 1997	Substantially Equivalent	Seirin-America, Inc.
K964529	CW ACUPUNCTURE NEEDLES	Jan 30, 1997	Substantially Equivalent	Lhasa Medical, Inc.
K964411	TAKI ACUPUNCTURE NEEDLES	Dec 31, 1996	Substantially Equivalent	Lhasa Medical, Inc.
K964051	NEEDLE, ACUPUNCTURE	Nov 05, 1996	Substantially Equivalent	S-Tcm Enterprises, Inc.
K961677	ACUPUNCTURE NEEDLES	Oct 28, 1996	Substantially Equivalent	K.S. Choi Corp.
K963769	SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES	Oct 16, 1996	Substantially Equivalent	Seirin-America, Inc.
K963299	HWA-TO ACUPUNCTURE NEEDLES	Sep 30, 1996	Substantially Equivalent	Lhasa Medical, Inc.
K963300	DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES)	Sep 23, 1996	Substantially Equivalent	Lhasa Medical, Inc.
K963194	ITO ACUPUNCTURE NEEDLES	Aug 23, 1996	Substantially Equivalent	Oms Medical Supplies, Inc.
K962916	HUA-XIA ACUPUNCTURE NEEDLES	Aug 23, 1996	Substantially Equivalent	Lhasa Medical, Inc.
K962809	SEIRIN ACUPUNCTURE NEEDLES	Aug 16, 1996	Substantially Equivalent	Seirin-America, Inc.
K962787	TAKI DISPOSABLE ACUPUNCTURE NEEDLE	Jul 26, 1996	Substantially Equivalent	Acupuncture Supplies Import Co.
K962419	CW-DISPOSABLE ACUPUNCTURE NEEDLE	Jul 25, 1996	Substantially Equivalent	Acupuncture Supplies Import Co.
K960769	ACUPUNCTURE NEEDLE PACK	Jul 10, 1996	Substantially Equivalent	Acu-Med, Inc.
K961339	CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES	Jul 03, 1996	Substantially Equivalent	Helio Medical Supplies, Inc.