510(k) K210444
K210444 is an FDA 510(k) premarket notification submitted by Poonglim Pharmatech, Inc. for the device "EZ-Injec LDV Sterile Safety Needle". The FDA issued a decision of Substantially Equivalent on February 16, 2021. The device falls under product code QNS (Low Dead Space Needle, Single Lumen, Hypodermic), a Class II device regulated under 21 CFR 880.5570. Poonglim Pharmatech, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2021
- Date Received
- February 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low Dead Space Needle, Single Lumen, Hypodermic
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
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.