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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound Bronchoscope
510(k) Number K261616
Device Name Single-Use EBUS Balloon
Applicant
Micro-Tech (Nanjing) Co., Ltd.
#10 Gaoke Third Rd., Nanjing National Hi-Tech, Industrial De
# 199 Medicine Valley Ave., Nanjing National Hi-Tech, Indust
Nanjing,  CN 210032
Applicant Contact Sally He
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
#10 Gaoke Third Rd., Nanjing National Hi-Tech, Industrial De
# 199 Medicine Valley Ave., Nanjing National Hi-Tech, Indust
Nanjing,  CN 210032
Correspondent Contact Sally He
Regulation Number892.1550
Classification Product Code
PSV  
Date Received05/15/2026
Decision Date 10/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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