510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980469Substantially Equivalent

Kht Sooji Needle, Hand Acupuncture Needle

American Institute of Koryo Hand Therapy, Industry CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980469 is the FDA 510(k) clearance record for KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE, a class II device, cleared for American Institute of Koryo Hand Therapy on under FDA product code MQX (Needle, Acupuncture, Single Use). FDA records list 5 510(k) clearances for American Institute of Koryo Hand Therapy, from to . As of , FDA records show no recalls naming K980469.

Clearance record

Decision date
Received
(56 days to decision)
Product code
MQX Needle, Acupuncture, Single Use
Regulation
21 CFR 880.5580
Device class
Class II
Review panel
General Hospital
Applicant
American Institute of Koryo Hand Therapy 17870 Castleton St., Suite 265, Industry CA
510(k) summary
Summary
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