MQX · Class II · 21 CFR 880.5580

FDA Product Code MQX: Needle, Acupuncture, Single Use

Leading manufacturers include Helio Medical Supplies, Inc., Lhasa Medical, Inc. and American Institute of Koryo Hand Therapy.

91
Total
91
Cleared
106d
Avg days
1996
Since

FDA 510(k) Cleared Needle, Acupuncture, Single Use Devices (Product Code MQX)

91 devices
1–24 of 91
Cleared May 11, 2017
AIK Sterile Acupuncture Needles for Single Use
K162566
Changchun Aik Medical Devices Co., Ltd.
General Hospital · 239d
Cleared Aug 25, 2015
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
K142760
K.S. Choi Corporation
General Hospital · 334d
Cleared Jul 15, 2015
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
K150903
Maanshan Bond Medical Instruments Co., Ltd.
General Hospital · 103d
Cleared Jun 10, 2015
KM Needles (Acupuncture Needle)
K142920
K.M.S., Inc.
General Hospital · 245d
Cleared Aug 01, 2014
SMC ACUPUNCTURE NEEDLE
K141473
Smc Intl., Inc.
General Hospital · 59d
Cleared Dec 02, 2013
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
K132896
Asia-Med GmbH and CO KG
General Hospital · 77d
Cleared Nov 04, 2011
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
K111392
Woojeon Company
General Hospital · 170d
Cleared Jun 20, 2011
BIOMATE STERILE ACUPUNCTURE NEEDLE
K103061
Biomate Medical Devices Technology Co., Ltd.
General Hospital · 245d
Cleared Apr 21, 2010
ACUPUNCTURE NEEDLES
K092240
Haenglim Seowon Medical Co.
General Hospital · 272d
Cleared Aug 11, 2009
JIAJIAN ACUPUNCTURE NEEDLE
K090199
Wuxi Jiajian Medical Instrument Co., Ltd.
General Hospital · 196d
Cleared Jun 30, 2009
HANSO ACUPUNCTURE NEEDLE
K090910
Hansol Medical Co.
General Hospital · 90d
Cleared Apr 10, 2008
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
K071524
Tcm World, Inc.
General Hospital · 311d
Cleared Nov 19, 2007
BRIO ACUPUNCTURE NEEDLES
K072778
Helio Medical Supplies, Inc.
General Hospital · 52d
Cleared Nov 22, 2006
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES
K061517
Prime Herbs Corporation
General Hospital · 174d
Cleared Sep 20, 2006
LYRA ACUPUNCTURE NEEDLES
K062448
Helio Medical Supplies, Inc.
General Hospital · 29d
Cleared Apr 26, 2006
ASP TITANIUM
K060392
Sedatelec
General Hospital · 70d
Cleared Feb 01, 2006
KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES
K052731
Daxin LI
General Hospital · 125d
Cleared Jan 13, 2006
SEVEN STAR NEEDLE
K052723
Helio Medical Supplies, Inc.
General Hospital · 106d
Cleared Dec 22, 2005
TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE
K052846
Maanshan Medical Instruments Co., Ltd.
General Hospital · 76d
Cleared Oct 14, 2005
STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES
K052085
Asia-Med GmbH and CO KG
General Hospital · 73d
Cleared Mar 25, 2005
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
K050295
Helio Medical Supplies, Inc.
General Hospital · 46d
Cleared Feb 11, 2005
ACUPUNCTURE NEEDLES
K043506
Marknew Products
General Hospital · 53d
Cleared Feb 08, 2005
C&G ACUPUNCTURE NEEDLE
K043277
Helio Medical Supplies, Inc.
General Hospital · 74d
Cleared Dec 29, 2004
ACUPUNCTURE NEEDLES
K041652
C.A.I. Industries Corp.
General Hospital · 195d

About Product Code MQX - Regulatory Context