QNS
- Product code
- QNS
- Device name
- Low Dead Space Needle, Single Lumen, Hypodermic
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5570
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification definition
A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242956 | 2024-10-25 | Ocuject, LLC | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safet… | |
| K231734 | 2024-03-08 | Tsk Laboratory International Japan KK | STERiJECT Low Dead Space, STERiJECT The Invisible Ne… |
Official FDA classification page: QNS
Classification and pathway per current FDA publications. Data from openFDA (CC0).