QNS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Low Dead Space Needle, Single Lumen, Hypodermic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Medical specialty
- General Hospital
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (K242956) | Ocuject, LLC | 2024-10-25 |
| STERiJECT Low Dead Space, STERiJECT The Invisible Needle (K231734) | Tsk Laboratory International Japan KK | 2024-03-08 |
| EZ-Injec LDV Sterile Safety Needle (K210444) | Poonglim Pharmatech, Inc. | 2021-02-16 |
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Every clearance here is in the API, with alerts when new ones post.