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
K201342Substantially Equivalent

HANAROSTENT Trachea/Bronchium (CCC)

M.I.Tech Co Ltd, Pyeongtaek-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201342 is the FDA 510(k) clearance record for HANAROSTENT Trachea/Bronchium (CCC), a class II device, cleared for M.I.Tech Co., Ltd. on under FDA product code JCT (Prosthesis, Tracheal, Expandable). FDA records list 14 510(k) clearances for M.I.Tech Co., Ltd., from to . As of , FDA records show no recalls naming K201342.

Clearance record

Decision date
Received
(225 days to decision)
Product code
JCT Prosthesis, Tracheal, Expandable
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
M.I.Tech Co., Ltd. 174 Habuk 2-Gil, Jinwi-Myeon, Pyeongtaek-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JCT

Trailing 12 months

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

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