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The Tracker / October 2025 / K253327

510(k) cleared

HANAROSTENT Esophagus Upper (CCC)

M.I.Tech Co., Ltd. · Oct 30, 2025 · K253327

FDA cleared the HANAROSTENT Esophagus Upper (CCC) from M.I.Tech Co., Ltd. on Oct 30, 2025 under K253327, a special 510(k). The device falls under product code ESW, Prosthesis, Esophageal, regulated at 21 CFR 878.3610 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 30, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for M.I.Tech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253327?

K253327 is the FDA 510(k) for HANAROSTENT Esophagus Upper (CCC), submitted by M.I.Tech Co., Ltd.. FDA's decision date was Oct 30, 2025, under product code ESW (Prosthesis, Esophageal).

Who makes the HANAROSTENT Esophagus Upper (CCC)?

M.I.Tech Co., Ltd., based in Pyeongtaek-Si, Gyeonggi-Do, is the applicant of record for K253327.

How long did the K253327 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 30, 2025, 30 days later.

← All decisions in October 2025