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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K261637
Device Name Single-use Flexible Bronchoscope
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Bldg. 12, Innovation And Entrepreneurship Service Cente
No 9 Chuanqi W. Rd., Jiuhua Economic Development Zone
Xiangtan,  CN 411100
Applicant Contact Fei Lina
Correspondent
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Bldg. 12, Innovation And Entrepreneurship Service Cente
No 9 Chuanqi W. Rd., Jiuhua Economic Development Zone
Xiangtan,  CN 411100
Correspondent Contact Fei Lina
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received05/18/2026
Decision Date 09/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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