510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111392Substantially Equivalent

Woojeon Acupuncture Needle (=Sera Acupuncture Needle)

Woojeon Co., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111392 is the FDA 510(k) clearance record for WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE), a class II device, cleared for Woojeon Company on under FDA product code MQX (Needle, Acupuncture, Single Use). FDA records list one 510(k) clearance for Woojeon Company. As of , FDA records show no recalls naming K111392.

Clearance record

Decision date
Received
(170 days to decision)
Product code
MQX Needle, Acupuncture, Single Use
Regulation
21 CFR 880.5580
Device class
Class II
Review panel
General Hospital
Applicant
Woojeon Company 300, Atwood, Pittsburgh PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQX

Trailing 12 months

FDA records hold no clearances under product code MQX in the trailing twelve months.

FDA records show no clearances under product code MQX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260