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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K260933
Device Name Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
Applicant
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Rm. 104,201,301,302, Bldg. 12, Block 1,# 619 Wangmei Rd.,
Linping Subdistrict, Linping District
Hangzhou,  CN 310000
Applicant Contact Chen Meijun
Correspondent
Shanghai Lingfu Technology Co., Ltd.
Rm. 1115, Block A, Xuhui Vanke Centre, # 55 Ding'An Rd., Xuh
Shanghai,  CN 200235
Correspondent Contact Ren Jiangfeng
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/20/2026
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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