QNS — Low Dead Space Needle, Single Lumen, Hypodermic Class II
Classification Details
- Product Code
- QNS
- Device Class
- Class II
- Regulation Number
- 880.5570
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242956 | ocuject | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Saf | October 25, 2024 |
| K231734 | tsk laboratory international japan | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | March 8, 2024 |
| K210444 | poonglim pharmatech | EZ-Injec LDV Sterile Safety Needle | February 16, 2021 |