K210443 is an FDA 510(k) clearance for the PLPT LDV (Low Dead Volume) Sterile Syringe. This device is classified as a Low Dead Space Piston Syringe (Class II - Special Controls, product code QNQ).
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 880.5860. A Low Dead Space Syringe Is A Piston Syringe Designed To Reduce Medication Waste. The Device Consists Of A Calibrated Hollow Barrel, A Moveable Plunger, And May Include A Needle. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient..
| 510(k) Number | K210443 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 | QNQ - Low Dead Space Piston Syringe |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| Definition | A Low Dead Space Syringe Is A Piston Syringe Designed To Reduce Medication Waste. The Device Consists Of A Calibrated Hollow Barrel, A Moveable Plunger, And May Include A Needle. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient. |