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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 K250210
Device Name Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))
Applicant
Scivita Medical Technology Co., Ltd.
#2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Wu Ruqin
Correspondent
Scivita Medical Technology Co., Ltd.
#2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Correspondent Contact Jiang Dan
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received01/24/2025
Decision Date 03/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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