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510(k) K142760

Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles by K.S. Choi Corporation — Product Code MQX

K142760 is an FDA 510(k) premarket notification submitted by K.S. Choi Corporation for the device "Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles". The FDA issued a decision of Substantially Equivalent on August 25, 2015. 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
August 25, 2015
Date Received
September 25, 2014
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

  • K162566 — AIK Sterile Acupuncture Needles for Single Use (May 11, 2017)
  • 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)
  • K090910 — HANSO ACUPUNCTURE NEEDLE (June 30, 2009)

FDA data resources