510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113247Substantially Equivalent

Anesthesia Injection Tool Set

Ki Works Co., Ltd., Yongsan-Dong, Daejeon, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113247 is the FDA 510(k) clearance record for ANESTHESIA INJECTION TOOL SET, a class II device, cleared for Ki Works Co., Ltd. on under FDA product code EJI (Syringe, Cartridge). FDA records list one 510(k) clearance for Ki Works Co., Ltd. As of , FDA records show no recalls naming K113247.

Clearance record

Decision date
Received
(146 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Ki Works Co., Ltd. Migun Technowolrd 2, Yongsan-Dong, Daejeon, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EJI

Trailing 12 months

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

FDA records show no clearances under product code EJI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJI, 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