K210444 is an FDA 510(k) clearance for the EZ-Injec LDV Sterile Safety Needle. This device is classified as a Low Dead Space Needle, Single Lumen, Hypodermic (Class II - Special Controls, product code QNS).
Submitted by Poonglim Pharmatech, Inc. (Gunsan, KR). The FDA issued a Cleared decision on February 16, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. 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) Number | K210444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2021 |
| Decision Date | February 16, 2021 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QNS - Low Dead Space Needle, Single Lumen, Hypodermic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| 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. |