Home / 510(k) Clearances / K132896

510(k) K132896

CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE by Asia-Med GmbH and CO KG — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2013
Date Received
September 16, 2013
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 by Asia-Med GmbH and CO KG

  • K052085 — STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDL (October 14, 2005)
  • 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)

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  • K142920 — KM Needles (Acupuncture Needle) (June 10, 2015)
  • K141473 — SMC ACUPUNCTURE NEEDLE (August 1, 2014)
  • 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)