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510(k) K141473

SMC ACUPUNCTURE NEEDLE by Smc Intl., Inc. — Product Code MQX

K141473 is an FDA 510(k) premarket notification submitted by Smc Intl., Inc. for the device "SMC ACUPUNCTURE NEEDLE". The FDA issued a decision of Substantially Equivalent on August 1, 2014. 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 1, 2014
Date Received
June 3, 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)
  • K142920 — KM Needles (Acupuncture Needle) (June 10, 2015)
  • 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