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The Tracker / September 2026 / K261637

510(k) cleared

Single-use Flexible Bronchoscope

Hunan Vathin Medical Instrument Co., Ltd. · Sep 23, 2026 · K261637

FDA cleared the Single-use Flexible Bronchoscope from Hunan Vathin Medical Instrument Co., Ltd. on Sep 23, 2026 under K261637, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on May 18, 2026. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hunan Vathin Medical Instrument Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261637?

K261637 is the FDA 510(k) for Single-use Flexible Bronchoscope, submitted by Hunan Vathin Medical Instrument Co., Ltd.. FDA's decision date was Sep 23, 2026, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the Single-use Flexible Bronchoscope?

Hunan Vathin Medical Instrument Co., Ltd., based in Xiangtan, is the applicant of record for K261637.

How long did the K261637 review take?

FDA received the submission on May 18, 2026 and issued its decision on Sep 23, 2026, 128 days later.

← All decisions in September 2026