510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213251Substantially Equivalent

HANAROSTENT Esophagus Asymmetric (CCC)

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

K213251 is the FDA 510(k) clearance record for HANAROSTENT Esophagus Asymmetric (CCC), a class II device, cleared for M.I.Tech Co., Ltd. on under FDA product code ESW (Prosthesis, Esophageal). FDA records list 14 510(k) clearances for M.I.Tech Co., Ltd., from to . As of , FDA records show no recalls naming K213251.

Clearance record

Decision date
Received
(49 days to decision)
Product code
ESW Prosthesis, Esophageal
Regulation
21 CFR 878.3610
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 ESW

Trailing 12 months
1 clearance under product code ESW in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ESW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260