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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 K242793
Device Name Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.
Applicant
Shenzhen Insighters Medical Technology Co., Ltd.
The 13th Floor Of Hengtemei Bldg., Ganli Rd. #3
Shenzhen,  CN 518000
Applicant Contact Baohong Fang
Correspondent
Shenzhen Insighters Medical Technology Co., Ltd.
The 13th Floor Of Hengtemei Bldg., Ganli Rd. #3
Shenzhen,  CN 518000
Correspondent Contact Baohong Fang
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/16/2024
Decision Date 05/28/2025
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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