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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K260892
Device Name Suction Pump (SU-90)
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
401, 501, Bldg. 4, Haizhi Technology Park, Fortis, # 17, Bul
Xialilang Community, Nanwan St., Longgang District
Shenzhen,  CN 518112
Applicant Contact Joyce Huang
Correspondent
Shenzhen HugeMed Medical Technical Development Co., Ltd.
401, 501, Bldg. 4, Haizhi Technology Park, Fortis, # 17, Bul
Xialilang Community, Nanwan St., Longgang District
Shenzhen,  CN 518112
Correspondent Contact Joyce Huang
Regulation Number878.4780
Classification Product Code
BTA  
Date Received03/18/2026
Decision Date 05/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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