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510(k) K052731

KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES by Daxin LI — Product Code MQX

K052731 is an FDA 510(k) premarket notification submitted by Daxin LI for the device "KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES". The FDA issued a decision of Substantially Equivalent on February 1, 2006. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2006
Date Received
September 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Acupuncture, Single Use
Device Class
Class II
Regulation Number
880.5580
Review Panel
HO
Submission Type

Other clearances for product code MQX

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  • K142760 — Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles (August 25, 2015)
  • K150903 — EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, (July 15, 2015)
  • K142920 — KM Needles (Acupuncture Needle) (June 10, 2015)
  • K141473 — SMC ACUPUNCTURE NEEDLE (August 1, 2014)
  • K132896 — CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, (December 2, 2013)
  • K111392 — WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) (November 4, 2011)
  • K103061 — BIOMATE STERILE ACUPUNCTURE NEEDLE (June 20, 2011)
  • K092240 — ACUPUNCTURE NEEDLES (April 21, 2010)
  • K090199 — JIAJIAN ACUPUNCTURE NEEDLE (August 11, 2009)

FDA data resources