Product code MQX
- Device name
- Needle, Acupuncture, Single Use
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5580
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162566 | AIK Sterile Acupuncture Needles for Single Use | Changchun Aik Medical Devices Co., Ltd. | 2017-05-11 |
| K142760 | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | K.S. Choi Corporation | 2015-08-25 |
| K150903 | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural | Maanshan Bond Medical Instruments Co., Ltd. | 2015-07-15 |
| K142920 | KM Needles (Acupuncture Needle) | K.M.S., Inc. | 2015-06-10 |
| K141473 | SMC ACUPUNCTURE NEEDLE | Smc Intl., Inc. | 2014-08-01 |
| K132896 | CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE | Asia-Med GmbH and CO KG | 2013-12-02 |
| K111392 | WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) | Woojeon Company | 2011-11-04 |
| K103061 | BIOMATE STERILE ACUPUNCTURE NEEDLE | Biomate Medical Devices Technology Co., Ltd. | 2011-06-20 |
| K092240 | ACUPUNCTURE NEEDLES | Haenglim Seowon Medical Co. | 2010-04-21 |
| K090199 | JIAJIAN ACUPUNCTURE NEEDLE | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009-08-11 |
| K090910 | HANSO ACUPUNCTURE NEEDLE | Hansol Medical Co. | 2009-06-30 |
| K071524 | TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL | Tcm World, Inc. | 2008-04-10 |
| K072778 | BRIO ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | 2007-11-19 |
| K061517 | PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES | Prime Herbs Corporation | 2006-11-22 |
| K062448 | LYRA ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | 2006-09-20 |
| K060392 | ASP TITANIUM | Sedatelec | 2006-04-26 |
| K052731 | KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES | Daxin LI | 2006-02-01 |
| K052723 | SEVEN STAR NEEDLE | Helio Medical Supplies, Inc. | 2006-01-13 |
| K052846 | TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE | Maanshan Medical Instruments Co., Ltd. | 2005-12-22 |
| K052085 | STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES | Asia-Med GmbH and CO KG | 2005-10-14 |
| K050295 | PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | 2005-03-25 |
| K043506 | ACUPUNCTURE NEEDLES | Marknew Products | 2005-02-11 |
| K043277 | C&G ACUPUNCTURE NEEDLE | Helio Medical Supplies, Inc. | 2005-02-08 |
| K041652 | ACUPUNCTURE NEEDLES | C.A.I. Industries Corp. | 2004-12-29 |
| K042063 | PRESS TACK NEEDLE | Asia-Med GmbH & Co. Kg. - Werk Suhl | 2004-10-14 |
| K031818 | FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE | Facilai Enterprises , Ltd. | 2003-12-03 |
| K031250 | DBC PRESS ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2003-07-15 |
| K031060 | NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 2003-07-11 |
| K031716 | SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE | Asia-Med GmbH and CO KG | 2003-07-10 |
| K024207 | VINCO BRAND ACUPUNCTURE NEEDLE | Helio Medical Supplies, Inc. | 2003-04-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08150050217476 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217575 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217568 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217551 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217544 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217537 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217520 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217513 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217506 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217490 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217483 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217469 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217599 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-10-16 |
| 08150050217452 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-09-11 |
| 08150050217445 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-09-11 |
| 08150050217438 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-09-11 |
| 08150050217421 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-09-11 |
| 08150050217407 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-09-11 |
| 08150050217391 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-09-11 |
| 08150050217384 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-09-11 |
| 08150050217377 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-09-11 |
| 08150050217360 | ACE | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2017-08-29 |
| 08150050240818 | jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-11-25 |
| 08150050240825 | jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-11-25 |
| 08150050240832 | jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-11-25 |
| 08150050240849 | jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-11-25 |
| 08150050240856 | jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-11-25 |
| 08150050240863 | jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-11-25 |
| 08150050240887 | jiajian | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-11-25 |
| 08150050211122 | SHUNLI | Wuxi Jiajian Medical Instrument Co.,Ltd. | 2016-10-25 |