K231856 is an FDA 510(k) clearance for the TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)). This device is classified as a Low Dead Space Piston Syringe (Class II - Special Controls, product code QNQ).
Submitted by Medexel Co.,Ltd (Anseong, KR). The FDA issued a Cleared decision on March 15, 2024, 266 days after receiving the submission on June 23, 2023.
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 | K231856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2023 |
| Decision Date | March 15, 2024 |
| Days to Decision | 266 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. |