510(k) K260933 ยท FMI Needle, Hypodermic, Single Lumen
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, N
| Applicant | Hangzhou Qiantang Longyue Biotechnology Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Aug 7, 2026 |
| Received | Mar 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260933
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.