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510(k) K052846

TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE by Maanshan Medical Instruments Co., Ltd. — Product Code MQX

K052846 is an FDA 510(k) premarket notification submitted by Maanshan Medical Instruments Co., Ltd. for the device "TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE". The FDA issued a decision of Substantially Equivalent on December 22, 2005. 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
December 22, 2005
Date Received
October 7, 2005
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

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  • 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)

FDA data resources