K213013 is an FDA 510(k) clearance for the Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe. This device is classified as a Low Dead Space Piston Syringe (Class II - Special Controls, product code QNQ).
Submitted by Jeil Tech Co., Ltd. (Sejong-Si, KR). The FDA issued a Cleared decision on September 19, 2022, 364 days after receiving the submission on September 20, 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 | K213013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2021 |
| Decision Date | September 19, 2022 |
| Days to Decision | 364 days |
| 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. |