← Product Code [FMI](/productcode/FMI) · K260933

# 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) (K260933)

_Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · FMI · Aug 7, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260933

## Device Facts

- **Applicant:** Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- **Product Code:** [FMI](/productcode/FMI.md)
- **Decision Date:** Aug 7, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5570
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

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**Source:** [https://fda.innolitics.com/device/K260933](https://fda.innolitics.com/device/K260933)

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