K220083 is an FDA 510(k) clearance for the LDV((Low Dead Volume )Syringe. This device is classified as a Low Dead Space Piston Syringe (Class II - Special Controls, product code QNQ).
Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing, CN). The FDA issued a Cleared decision on May 25, 2022, 135 days after receiving the submission on January 10, 2022.
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 | K220083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2022 |
| Decision Date | May 25, 2022 |
| Days to Decision | 135 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. |