DeviceSignal · 510(k) cleared
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
FDA 510(k) decision recorded 2026-08-07 · K260933 · Traditional 510(k)
Event510(k) cleared
Effective2026-08-07
DecisionSESE
On 2026-08-07 the FDA recorded a 510(k) clearance decision for Hangzhou Qiantang Longyue Biotechnology Co., Ltd., for Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R…. Clearance K260933. Product code FMI. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K260933
- Applicant
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- Device
- 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)
- Decided on
- 2026-08-07
- Received on
- 2026-03-20
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- FMI
- Review days
- 140
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K260933- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
b4baec28e2fa713393f4c913493b6cd9aada0126dc2ac35a8d50786c002b93ad- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)