Home / 510(k) Clearances / K052085

510(k) K052085

STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES by Asia-Med GmbH and CO KG — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2005
Date Received
August 2, 2005
Clearance Type
Special
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 by Asia-Med GmbH and CO KG

  • K132896 — CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, (December 2, 2013)
  • K031716 — SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE (July 10, 2003)
  • K011808 — ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) (July 10, 2001)

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)