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510(k) K142920

KM Needles (Acupuncture Needle) by K.M.S., Inc. — Product Code MQX

K142920 is an FDA 510(k) premarket notification submitted by K.M.S., Inc. for the device "KM Needles (Acupuncture Needle)". The FDA issued a decision of Substantially Equivalent on June 10, 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
June 10, 2015
Date Received
October 8, 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)
  • 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)
  • 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